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https://www.docsj.com/doc/a58257723.html,/content/144/1_suppl/S1The online version of this article can be found at:

DOI: 10.1177/0194599810389949

2011 144: S1

Otolaryngology -- Head and Neck Surgery R. Wald, Eric Wall, Gemma Sandberg and Milesh M. Patel Darrow, Terri Giordano, Ronald S. Litman, Kasey K. Li, Mary Ellen Mannix, Richard H. Schwartz, Gavin Setzen, Ellen

Reginald F. Baugh, Sanford M. Archer, Ron B. Mitchell, Richard M. Rosenfeld, Raouf Amin, James J. Burns, David H.Clinical Practice Guideline : Tonsillectomy in Children

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Clinical Practice Guideline: T onsillectomy in Children

Reginald F . Baugh, MD 1, Sanford M. Archer, MD 2,

Ron B. Mitchell, MD 3, Richard M. Rosenfeld, MD, MPH 4,

Raouf Amin, MD 5, James J. Burns, MD 6, David H. Darrow, MD, DDS 7, T erri Giordano, MSN, CRNP , CORLN 8, Ronald S. Litman, DO 9, Kasey K. Li, MD, DDS 10, Mary Ellen Mannix, MRPE 11, Richard H. Schwartz, MD 12, Gavin Setzen, MD 13, Ellen R. Wald, MD 14, Eric Wall, MD, MPH 15,

Gemma Sandberg, MA 16, and Milesh M. Patel, MS 17

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Abstract

Objective. T onsillectomy is one of the most common surgical procedures in the United States, with more than 530 000 pro-cedures performed annually in children younger than 15 years. T onsillectomy is defined as a surgical procedure performed with or without adenoidectomy that completely removes the tonsil including its capsule by dissecting the peritonsil-lar space between the tonsil capsule and the muscular wall. Depending on the context in which it is used, it may indicate tonsillectomy with adenoidectomy, especially in relation to sleep-disordered breathing. This guideline provides evidence-based recommendations on the preoperative, intraoperative, and postoperative care and management of children 1 to 18 years old under consideration for tonsillectomy. In addition, this guideline is intended for all clinicians in any setting who interact with children 1 to 18 years of age who may be candi-dates for tonsillectomy.

Purpose. The primary purpose of this guideline is to provide clinicians with evidence-based guidance in identifying children who are the best candidates for tonsillectomy. Secondary objectives are to optimize the perioperative management of children undergoing tonsillectomy, emphasize the need for evaluation and intervention in special populations, improve counseling and education of families of children who are con-sidering tonsillectomy for their child, highlight the manage-ment options for patients with modifying factors, and reduce inappropriate or unnecessary variations in care.

Results. The panel made a strong recommendation that clinicians should administer a single, intraoperative dose of intravenous dexamethasone to children undergoing tonsillectomy. T he panel made a strong recommendation against clinicians routinely admin-istering or prescribing perioperative antibiotics to children undergoing tonsillectomy. The panel made recommendations for

(1) watchful waiting for recurrent throat infection if there have been fewer than 7 episodes in the past year or fewer than 5 episodes per year in the past 2 years or fewer than 3 episodes per year in the past 3 years; (2) assessing the child with recur-rent throat infection who does not meet criteria in statement 2 for modifying factors that may nonetheless favor tonsillectomy, which may include but are not limited to multiple antibiotic allergy/intolerance, periodic fever, aphthous stomatitis, pharyn-gitis and adenitis, or history of peritonsillar abscess; (3) asking caregivers of children with sleep-disordered breathing and ton-sil hypertrophy about comorbid conditions that might improve after tonsillectomy, including growth retardation, poor school performance, enuresis, and behavioral problems; (4) counseling caregivers about tonsillectomy as a means to improve health in children with abnormal polysomnography who also have tonsil hypertrophy and sleep-disordered breathing; (5) counsel-ing caregivers that sleep-disordered breathing may persist or recur after tonsillectomy and may require further management; (6) advocating for pain management after tonsillectomy and educating caregivers about the importance of managing and reassessing pain; and (7) clinicians who perform tonsillectomy should determine their rate of primary and secondary post-tonsillectomy hemorrhage at least annually. The panel offered options to recommend tonsillectomy for recurrent throat infec-tion with a frequency of at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years with documentation in the medical record for each episode of sore throat and 1 or more of the following: temperature >38.3°C, cervical adenopathy, tonsillar exudate, or positive test for group A b -hemolytic streptococcus. Keywords

tonsillectomy, adenotonsillectomy, tonsillitis, sleep disordered breathing, pediatric guideline

Received August 2, 2010; revised September 10, 2010; accepted September 15, 2010.

Guideline

S2 Otolaryngology–Head and Neck Surgery 144(1S)

T onsillectomy is one of the most common surgical pro-cedures in the United States, with more than 530 000

procedures performed annually in children younger than 15 years.1 Indications for surgery include recurrent throat infections and sleep-disordered breathing (SDB),2both of which can substantially affect child health status and quality of life (QoL). Although there are benefits of tonsillectomy, complications of surgery may include throat pain, postopera-tive nausea and vomiting, delayed feeding, voice changes, hemorrhage, and rarely death. The frequency of tonsillectomy, associated morbidity, and availability of hundreds of random-ized clinical trials assessing interventions create a pressing need for evidence-based guidance to aid clinicians.

This document is intended for all clinicians who diagnose or manage patients aged 1 to 18 years for whom tonsillec-tomy is being considered for indications of recurrent throat infection and/or SDB as defined as follows:

?Tonsillectomy is defined as a surgical procedure per-formed with or without adenoidectomy that

completely removes the tonsil, including its capsule,

by dissecting the peritonsillar space between the

tonsil capsule and the muscular wall. Depending on

the context in which it is used, it may indicate tonsil-

lectomy with adenoidectomy, especially in relation

to SDB.

?Throat infection is defined as sore throat caused by viral or bacterial infection of the pharynx, palatine

tonsils, or both, which may or may not be culture

positive for group A streptococcus. This includes the

terms strep throat and acute tonsillitis, pharyngitis,

adenotonsillitis, or tonsillopharyngitis.

?Sleep-disordered breathing is characterized by abnor-malities of respiratory pattern or the adequacy of

ventilation during sleep, which include snoring, mouth

breathing, and pauses in breathing. SDB encompasses

a spectrum of obstructive disorders that increases in

severity from primary snoring to obstructive sleep

apnea (OSA). Daytime symptoms associated with

SDB may include excessive sleepiness, inattention,

poor concentration, and hyperactivity.

?Caregiver is used throughout the document to refer to parents, guardians, or other adults providing care

to patients undergoing tonsillectomy.

The importance of tonsillectomy as an intervention relates to its documented benefit on child QoL. For example, when compared with healthy children, children with recurrent throat infections have more bodily pain and poorer general health and physical functioning.3 Tonsillectomy may improve QoL by reducing throat infections, health care provider visits, and the need for antibiotic therapy.4 Similarly, SDB is associated with cognitive and behavioral impairment in children that usually improves after tonsillectomy5-8 along with QoL,6,9-12 sleep disturbance,5,10,13,14 and vocal quality.15,16

Wide variations in tonsillectomy rates have been reported across the world, including Japan,17 Canada,18 the United King-dom,19and the United States.20Such variations are usually ascribed to heterogeneity in clinical practice and training rather than to differences in clinical need.21 The current lack of consen-sus in the United States on surgical indications and perioperative management further supports the need for an evidence-based clinical practice guideline to highlight best practices. Guideline Scope and Purpose

This guideline is intended for all clinicians in any setting who interact with children aged 1 to 18 years who may be candi-dates for tonsillectomy. The guideline does not apply to tonsillotomy, intracapsular surgery, or other partial removal techniques of the tonsil because of the relatively sparse high-quality published evidence on these techniques and limited long-term follow-up. Similarly, the guideline does not apply to populations of children excluded from most tonsillectomy research studies, including those with diabetes mellitus, car-diopulmonary disease, craniofacial disorders, congenital anomalies of the head and neck region, sickle cell disease, and other coagulopathies or immunodeficiency disorders.

The primary purpose of this guideline is to provide clinicians with evidence-based guidance in identifying children who are the best candidates for tonsillectomy. Secondary objectives are to optimize the perioperative management of children undergo-ing tonsillectomy, emphasize the need for evaluation and intervention in special populations, improve counseling and education of families of children who are considering tonsillec-tomy for their child, highlight the management options for patients with modifying factors, and reduce inappropriate or unnecessary variations in care. Lastly, we sought to identify gaps in knowledge that would guide future research. This guideline predominantly addresses indications for tonsillectomy based on

1Department of Surgery, University of T oledo Medical Center, T oledo, Ohio, USA; 2Division of Otolaryngology-Head & Neck Surgery, University of Kentucky Chandler Medical Center, Lexington, Kentucky, USA; 3Cardinal Glennon Children’s Medical Center, Saint Louis University School of Medicine, St Louis, Missouri, USA; 4Department of Otolaryngology, SUNY Downstate Medical Center and Long Island College Hospital, Brooklyn, New Y ork, USA; 5Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; 6Department of Pediatrics, Baystate Children’s Hospital, Springfield, Massachusetts, USA; 7Department of Otolaryngology, Eastern Virginia Medical School, Norfolk, Virginia, USA; 8Division of Otolaryngology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; 9Department of Anesthesiology and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; 10Sleep Apnea Surgery Center, East Palo Alto, California, USA; 11James’s Project, Wayne, Pennsylvania, USA; 12Advanced Pediatrics, Vienna, Virginia, USA; 13Albany ENT & Allergy Services, PC, Albany, New Y ork, USA; 14Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA; 15Qualis Health, Seattle, Washington, USA; 16The Cochrane ENT Disorders Group, Oxford, United Kingdom; 17American Academy of Otolaryngology—Head and Neck Surgery Foundation, Alexandria, Virginia, USA

Corresponding Author:

Reginald F. Baugh, MD, Professor and Chief, Otolaryngology-Head and Neck Surgery, Dowling Hall 2124 Mail Stop 1095, 3000 Arlington Avenue, T oledo, OH 43614; Email: reginald.baugh@https://www.docsj.com/doc/a58257723.html,

Baugh et al S3

obstructive and infectious causes. Other indications for surgery, including orthodontic concerns, tonsiliths, halitosis, and chronic tonsillitis, are not extensively discussed. The evidence in these areas is limited and generally of lesser quality, and a role for shared decision making is present.

This guideline is intended to focus on quality improvement opportunities judged most important by the working group. It is not intended to be a comprehensive, general guide for man-aging patients undergoing tonsillectomy. In this context, the purpose is to define useful actions for clinicians, regardless of discipline, to improve the quality of care. Conversely, the statements in this guideline are not intended to limit or restrict care provided by clinicians based on the assessment of indi-vidual patients.

Although there is evidence to guide management of certain aspects of tonsillectomy, there is no evidence-based clinical practice guideline relevant to all specialties managing such patients in the United States. A guideline is warranted because of documented practice variations in the care of patients who undergo tonsillectomy and the morbidity and mortality associ-ated with this surgical intervention.

Health Care Burden

Incidence of Tonsillectomy

Tonsillectomy is the second most common ambulatory surgi-cal procedure performed on children in the United States.1 In 2006, there were 530 000 tonsillectomies performed in chil-dren younger than 15 years, constituting 16% of all ambulatory surgery in this age group. The only procedure with greater fre-quency was myringotomy with insertion of tube, for which 667 000 procedures were reported the same year.

Between 1915 and the1960s, tonsillectomy was the most frequently performed surgical procedure in the United States. Data in 1993 from the National Hospital Discharge Survey, however, noted a decrease of more than 50% in inpatient ton-sillectomy rates from 1977 to 1989.22Similar reports from 1978 to 1986 showed that the rate of tonsillectomy for treat-ment of throat infections declined; however, the frequency of SDB as the primary indication for the procedure increased.2 A recent study reported that the overall incidence rates of tonsil-lectomy have significantly increased in the past 35 years, with SDB being the primary indication for surgery.23 Indications for Surgery

The 2 most common indications for tonsillectomy are recur-rent throat infections and SDB. Throat infections are a common reason to see a primary care physician and often result in antibiotic treatment.24 The cost of outpatient visits and the medications prescribed for sore throats including anti-biotics are substantial. Indirect costs associated with throat infections and SDB are substantial due to missed school and loss of time from work for caregivers.

Treatment of SDB is associated with an increase in health care utilization and cost. Children with SDB, compared with controls, have a significantly higher rate of antibiotic use, 40% more hospital visits,and an overall elevation of 215% in health care usage mostly from increased respiratory tract infections.25Children with tonsillar disease, including chil-dren with throat infections and SDB, also showed significantly lower scores on several QoL subscales including general health, physical functioning, behavior, bodily pain, and care-giver impact when compared with healthy children.3 SDB represents a spectrum of disorders ranging in severity from primary snoring to OSA. The prevalence of OSA in the pediatric population is 1% to 4%26; as many as 10% of chil-dren have primary snoring.27 Up to 30% to 40% of children with clinically diagnosed SDB exhibit behavioral problems that include enuresis,28hyperactivity, aggression, anxiety, depression, and somatization.29 OSA is also associated with poor school performance and a decrease in QoL.8 The QoL of children with OSA is similar to children with chronic condi-tions such as asthma and juvenile rheumatoid arthritis.30 Controversy persists about the actual benefits of tonsillec-tomy as compared with observation and medical treatment of throat infections. Although tonsillectomy for recurrent throat infections in severely affected children has been shown in a ran-domized controlled trial to reduce the frequency and severity of infections in the 2 years following surgery,31 the same cannot be shown for less severe cases or for a period greater than 2 years after surgery.20,31Observational studies, however, show improved disease-specific and global QoL after tonsillectomy for recurrent or chronic sore throat, as measured by validated instruments.4 These children suffered fewer infections after sur-gery, resulting in fewer antibiotics and physician visits.

A growing body of evidence indicates that tonsillectomy is an effective treatment for SDB,32 based on the idea that tonsil-lar hypertrophy is a principal cause. A meta-analysis of case series33and a recent study34showed that tonsillectomy was effective at improving or resolving SD

B in most children. There is also evidence that behavioral parameters, school per-formance, and QoL improve after resolution of this sleep disorder.8

Harms and Adverse Events of Tonsillectomy Tonsillectomy is a surgical procedure with an associated mor-bidity that includes possible hospitalization, risks of anesthesia, prolonged throat pain, and financial costs. A common complication of tonsillectomy is bleeding during or after the surgery. In published reports, the rate of primary hemorrhage (within 24 hours of surgery) has ranged from 0.2% to 2.2% and the rate of secondary hemorrhage (more than 24 hours after surgery) from 0.1% to 3%.35 Hemorrhage after tonsillectomy may result in readmission for observation or in further surgery to control bleeding.

Other complications of tonsillectomy are diverse and have been well described.36Operative complications include trauma to the teeth, larynx, pharyngeal wall, or soft palate; difficult intubation; laryngospasm; laryngeal edema; aspira-tion; respiratory compromise; endotracheal tube ignition; and cardiac arrest. Injury to nearby structures has been reported, including lip burn, eye injury, and fracture of the mandibular condyle. Postoperative complications include nausea, vomiting, pain, dehydration, referred otalgia, postobstructive pulmonary

S4 Otolaryngology–Head and Neck Surgery 144(1S)

edema, velopharyngeal insufficiency, and nasopharyngeal stenosis. Complications are more common in patients with cra-niofacial disorders, Down syndrome, cerebral palsy, major heart disease, or bleeding diatheses and in children younger than 3 years with polysomnography (PSG)–proven OSA.37-41 After tonsillectomy, about 1.3% of patients experience delayed discharge during the initial hospital stay, and up to 3.9% have secondary complications requiring readmission.42 The primary reasons for readmission or prolonged initial stay included pain, vomiting, fever, and tonsillar hemorrhage. In addition to these common causes of morbidity, many unusual and rare complications of tonsillectomy have also been described.43 Among these are reports of vascular injury, sub-cutaneous emphysema, jugular vein thrombosis, atlantoaxial subluxation (Grisel syndrome), taste disorders (hypogeusia, ageusia, dysgeusia, and phantogeusia), and persistent neck pain (Eagle syndrome).

Mortality rates for tonsillectomy have been estimated at between 1 in 16 000 to 1 in 35 000, based on data from the 1970s.44 There are no current estimates of tonsillectomy mor-tality, but a prospective audit reported only 1 postoperative death after 33 921 procedures in England and Northern Ire-land.42 About one-third of deaths are attributable to bleeding, while the remainder are related to aspiration, cardiopulmonary failure, electrolyte imbalance, or anesthetic complications.35,45 Similarly, airway compromise is the major cause of death or major injury in malpractice claims after tonsillectomy.46 Structure and Function of the Tonsils

The palatine tonsils are lymphoepithelial organs located at the junction of the oral cavity and the oropharynx. They are stra-tegically positioned to serve as secondary lymphoid organs, initiating immune responses against antigens entering the body through the mouth or nose. The greatest immunological activity of the tonsils is found between the ages of 3 and 10 years.47 As a result, the tonsils are most prominent during this period of childhood and subsequently demonstrate age-dependent involution.48

The epithelium of the tonsils is cryptic and reticulated and contains a system of specialized channels lined by “M” cells.49 These cells take up antigens into vesicles and transport them to the extrafollicular region or the lymphoid follicles. In the extrafollicular region, interdigitating dendritic cells and mac-rophages process the antigens and present them to helper T lymphocytes. These lymphocytes stimulate proliferation of follicular B lymphocytes and their development into either antibody-expressing B memory cells capable of migration to the nasopharynx and other sites or plasma cells that produce antibodies and release them into the lumen of the crypt.49 While all 5 immunoglobulin (Ig) isotypes are produced in the palatine tonsils, IgA is arguably the most important prod-uct of the tonsillar immune system. In its dimeric form, IgA may attach to the transmembrane secretory component to form secretory IgA, a critical component of the mucosal immune system of the upper airway. Although the secretory component is produced only in the extratonsillar epithelium, the tonsils do produce immunocytes bearing the J (joining) chain carbohydrate.50This component is necessary for bind-ing of IgA monomers to each other and to the secretory component and is an important product of B-cell activity in the follicles of the tonsil.

Effects of Tonsillitis and Tonsillectomy on Immunity

With chronic or recurrent tonsillitis, the controlled process of antigen transport and presentation is altered due to shedding of the M cells from the tonsil epithelium.49 The direct influx of antigens disproportionately expands the population of mature B-cell clones and, as a result, fewer early memory B cells go on to become J-chain–positive IgA immunocytes. In addition, the tonsillar lymphocytes can become so overwhelmed with persistent antigenic stimulation that they may be unable to respond to other antigens. Once this immunological impair-ment occurs, the tonsil is no longer able to function adequately in local protection, nor can it appropriately reinforce the secre-tory immune system of the upper respiratory tract. There would therefore appear to be a therapeutic advantage to removing recurrently or chronically diseased tonsils. On the other hand, some studies demonstrate minor alterations of Ig concentrations in the serum and adjacent tissues following tonsillectomy.51-54Nevertheless, there are no studies to date that demonstrate a significant clinical impact of tonsillectomy on the immune system.51-53

Methods and Literature Search

The guideline was developed using an explicit and transparent a priori protocol for creating actionable statements based on supporting evidence and the associated balance of benefit and harm.55 The guideline panel was chosen to represent fields of sleep medicine, advanced practice nursing, anesthesiology, infectious disease, family medicine, otolaryngology–head and neck surgery, pediatrics, and consumers. Several group mem-bers had prior experience in developing clinical practice guidelines.

The systematic literature search was divided into 2 stages and aimed to identify clinical practice guidelines, systematic reviews, or meta-analyses (stage I) and randomized controlled trials (stage II) using key biomedical literature databases (T able 1). The search was based on the string tonsillectom*, adenotonsillectom*, tonsillotom*, posttonsillectom*, (tonsil* OR adenotonsil*) AND (surg* OR operat* OR remov* OR preop* OR periop* OR postop*). Results were screened to remove duplicates and citations that were not pertinent.

1. Published and unpublished consensus- and evidence-

based clinical practice guidelines less than 10 years

old in English met inclusion criteria. The final

data set included 17 guidelines, and of those, 2

guidelines56,57met quality criteria of having been

produced under the auspices of a medical associa-

tion or organization and having an explicit, a priori,

method for ranking evidence and linking evidence

to recommendations.

2. Systematic reviews less than 15 years and meta-

analyses with a systematic review in English met

Baugh et al S5

inclusion criteria. The search filter used to identify

systematic reviews in PubMed was devised based

on the search strategy used by the National Health

Service Evidence–Cancer.58Reviews that met a

rating of adequate required a clear objective,

explicit search strategy, and valid data extraction.

The final data set included 36 systematic reviews

(including 9 Cochrane systematic reviews).

3. Randomized controlled trials published in English

with no age restrictions were identified using an

adaptation of the Cochrane Highly Sensitive Search

Strategy.59Published or unpublished completed

trials with a definite or possible randomized con-

trolled design met inclusion criteria. The final data

set yielded 705 studies that were grouped into the

following broad topics: analgesia (193), technique

(125), anesthesia (67), nausea/vomiting (62),

hemostasis (45), recovery (35), steroids (26), surgi-

cal indications (24), antibiotics (16), outcomes

assessment (15), surgical complications (2), periop-

erative care (2), and other (93).

Results of the literature searches were distributed to guideline panel members at the first meeting, including electronic listings with abstracts (if available) of the searches for guidelines, randomized controlled trials, and systematic reviews. This material was supplemented, as needed, with targeted systematic searches to address specific needs identified in developing the guideline through April 11, 2010.

In a series of conference calls, the working group defined the scope and objectives of the proposed guideline. During the 9 months devoted to guideline development ending in 2010, the group met twice with interval electronic review and feed-back on each guideline draft to ensure accuracy of content and consistency with standardized criteria for reporting clinical practice guidelines.60

The Guideline Implementability Appraisal and Extractor tool61 was used to appraise adherence of the draft guideline to method-ological standards, to improve clarity of recommendations, and to predict potential obstacles to implementation. Guideline panel members received summary appraisals in May 2010 and modi-fied an advanced draft of the guideline. The final draft guideline was distributed to a multidisciplinary group of 44 external reviewers, representing the target audience, for feedback and comment. Responses were compiled, reviewed by a subgroup of the panel, and incorporated into the guideline. The document was then submitted to the journal’s peer-review process before publi-cation. A scheduled review process will occur at 5 years from publication or sooner if new compelling evidence warrants ear-lier consideration.

Classification of Evidence-Based Statements

Guidelines are intended to reduce inappropriate variations in clinical care, to produce optimal health outcomes for patients, and to minimize harm. The evidence-based approach to guide-line development requires that the evidence supporting a policy be identified, appraised, and summarized and that an explicit link between evidence and statements be defined. Evidence-based statements reflect both the quality of evidence and the balance of benefit and harm that is anticipated when the statement is followed. The definitions for evidence-based statements62 are listed in T ables 2 and 3.

Guidelines are never intended to supersede professional judgment; rather, they may be viewed as a relative constraint on individual clinician discretion in a particular clinical cir-cumstance. Less frequent variation in practice is expected for a “strong recommendation” than might be expected with a “recommendation.” “Options” offer the most opportunity for practice variability.63 Clinicians should always act and decide in a way that they believe will best serve their patients’ interests and needs, regardless of guideline recommendations. Guide-lines represent the best judgment of a team of experienced clinicians and methodologists addressing the scientific evi-dence for a particular topic.62

Making recommendations about health practices involves value judgments on the desirability of various outcomes associ-ated with management options. V alues applied by the guideline

T able 1. Databases Housing Guidelines, Systematic Reviews, and Randomized Controlled T rials

Guidelines Systematic Reviews Randomized Controlled T rials

National Guidelines Clearinghouse CMA Infobase (Canada)

NHS Evidence ENT & Audiology (UK) National Library of Guidelines (UK) NICE (UK)

SIGN (Scotland)

New Zealand Guidelines Group Australian National Health and Medical Research Council

TRIP Database

PubMed

GIN NHS Evidence ENT & Audiology (UK)

Cochrane Library (Cochrane Database of

Systematic Reviews, DARE, HTA Database,

NHS EED)

TRIP Database

PubMed

EMBASE

CINAHL

AMED

BIOSIS Previews

CAB Abstracts

ISI Web of Science

AHRQ

HSTAT

Cochrane ENT Disorders Group T rials Register

CENTRAL (Cochrane Library)

HTA Database (Cochrane Library)

PubMed

EMBASE

CINAHL

AMED

BIOSIS Previews

CAB Abstracts

ISI Web of Science

https://www.docsj.com/doc/a58257723.html,

mRCT

ICTRP

TRIP Database

S6 Otolaryngology–Head and Neck Surgery 144(1S)

panel sought to minimize harm and diminish unnecessary and inappropriate therapy. A major goal of the committee was to maintain transparency and be explicit about how values were applied and to document the process.

Financial Disclosure

and Conflicts of Interest

The cost of developing this guideline, including travel expenses of all panel members, was covered in full by the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) Foundation. Potential conflicts of interest for all panel members were compiled and distributed before the first confer-ence call. After review and discussion of these disclosures,64 the panel concluded that individuals with potential conflicts could remain on the panel if they: (1) reminded the panel of potential conflicts before any related discussion, (2) recused themselves from a related discussion if asked by the panel, and (3) agreed not to discuss any aspect of the guideline with indus-try before publication. Lastly, panelists were reminded that conflicts of interest extend beyond financial relationships and may include personal experiences, how a participant earns a living, and the participant’s previously established “stake” in an issue.65

Guideline Key Action Statements

Each evidence-based statement is organized in a similar fashion: an evidence-based statement in bold, followed by a strength of the recommendation in italic.Several para-graphs subsequently discuss the evidence base supporting the statement, concluding with an “evidence profile” of aggregate evidence quality, benefit-harm assessment, and statement of costs. Lastly, there is an explicit statement of the value judgments, the role of patient preferences, clarifi-cation of any intentional vagueness by the panel, and a repeat statement of the strength of the recommendation. An

T able 2. Guideline Definitions for Evidence-Based Statements

Statement Definition Implication

Strong recommendation A strong recommendation means the benefits of the

recommended approach clearly exceed the harms (or

that the harms clearly exceed the benefits in the case

of a strong negative recommendation) and that the

quality of the supporting evidence is excellent (Grade

A or B).a In some clearly identified circumstances,

strong recommendations may be made based

on lesser evidence when high-quality evidence is

impossible to obtain and the anticipated benefits

strongly outweigh the harms.Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.

Recommendation A recommendation means the benefits exceed the

harms (or that the harms exceed the benefits in the

case of a negative recommendation), but the quality

of evidence is not as strong (Grade B or C).a In some

clearly identified circumstances, recommendations

may be made based on lesser evidence when high-

quality evidence is impossible to obtain and the

anticipated benefits outweigh the harms.Clinicians should generally follow a recommendation but should remain alert to new information and sensitive to patient preferences.

Option An option means that either the quality of evidence

that exists is suspect (Grade D)a or that well-done

studies (Grade A, B, or C)a show little clear advantage

to one approach versus another.Clinicians should be flexible in their decision making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role.

No recommendation No recommendation means there is both a lack of

pertinent evidence (Grade D)a and an unclear balance

between benefits and harms.Clinicians should feel little constraint in their decision making and be alert to new published evidence that clarifies the balance of benefit versus harm; patient preference should have a substantial influencing role.

a See T able 3 for definition of evidence grades.

T able 3. Evidence Quality for Grades of Evidence

Grade Evidence Quality

A Well-designed randomized controlled trials or diagnostic

studies performed on a population similar to the

guideline’s target population

B Randomized controlled trials or diagnostic studies with

minor limitations; overwhelmingly consistent evidence

from observational studies

C Observational studies (case control and cohort design)

D Case reports, reasoning from first principles (bench

research or animal studies)

X Exceptional situations in which validating studies cannot be performed and there is a clear preponderance of

benefit over harm

Baugh et al

S7

overview of evidence-based statements in the guideline and their interrelationship is shown in T able 4.

The role of patient preference in making decisions deserves further clarification. For some statements, the evidence base may demonstrate clear benefit, which would minimize the role of patient preference. If the evidence is weak or benefits are unclear, however, not all informed patients might opt to follow the suggestion. In these cases, the practice of shared decision making, where the management decision is made by a collaborative effort between the clinician and the informed patient, becomes more useful. Factors related to patient pref-erence include (but are not limited to) absolute benefits (number needed to treat), adverse effects (number needed to harm), cost of drugs or procedures, and frequency and dura-tion of treatment.

STATEMENT 1. WATCHFUL WAITING FOR RECUR-RENT THROAT INFECTION: Clinicians should recommend watchful waiting for recurrent throat infec-tion if there have been fewer than 7 episodes in the past year or fewer than 5 episodes per year in the past 2 years or fewer than 3 episodes per year in the past 3 years. Recommendation based on randomized controlled trials with limitations and observational studies with a prepon-derance of benefit over harm.

Supporting Text

The purpose of this statement is to avoid unnecessary inter-vention in children with recurrent throat infection who have a favorable natural history and are likely to improve on their own without surgery. Watchful waiting does not imply inac-tion; rather, patients should be closely monitored and episodes of pharyngotonsillitis accurately documented.

Throat infections are treated most often by the primary care provider, but other clinicians may be involved (eg, health care providers at emergency departments or urgent care centers). The primary care provider should collate documentation of all

such visits. In addition, the primary care provider should edu-cate the caregiver on acquiring and maintaining an at-home record of the child’s throat infection and health history. The clinical characteristics of each episode should include the symptoms, physical findings, and culture results if performed, as well as days of school absence and any QoL issues. Only with this information can the clinician assess the significance of the impact of recurrent pharyngotonsillitis for the patient and caregiver.

The importance of documentation cannot be overempha-sized. In one study of patients observed for 1 year, only 17% of patients meeting the “Paradise criteria” (T able 5) actually had adequate documentation and confirmation of their clinical course.66 This may have been due to information that was overstated by caretakers or to a tendency for recurrences to diminish over time.

History less than 12 months . There are currently no random-ized controlled trials investigating the efficacy of tonsillectomy for patients experiencing recurrent tonsillitis over a period of less than 12 months. Although the 3 best randomized controlled trials assessing the efficacy of tonsillectomy differed in study entry requirements (ie, the frequency and severity of recurrent pharyngotonsillitis), they all required a minimum number of sore throats in the preceding 12 months.20,31,66 For example, in the study by Paradise et al,31 62 (33%) of the 187 children that satisfied the Paradise criteria had 7 or more throat infections in the preceding 12 months. It is possible that all the reported infections occurred in a shorter period than 12 months, but these data were not reported. Furthermore, one of these studies 66 explicitly observed children with recurrent throat infections and found high rates of spontaneous resolution over 12 months. Because of this tendency to improve with time, at least a 12-month period of observation is recommended prior to con-sideration of tonsillectomy as an intervention.

This statement should not restrict access to tonsillectomy prior to 1 year of observation for all patients who do not meet frequency criteria for tonsillectomy (see Statement 3). Patients

T able 4. Summary of Evidence-Based Statements Point of Care (Evidence-Based Statement)Statement Strength

Surgical indications and planning Watchful waiting (Statement 1)

Recommendation Recurrent throat infection with documentation (Statement 2)

Option

T onsillectomy for recurrent infection with modifying factors (Statement 3)Recommendation T onsillectomy for sleep-disordered breathing (Statement 4)Recommendation T onsillectomy and polysomnography (Statement 5)Recommendation

Outcome assessment for sleep-disordered breathing (Statement 6)Recommendation

Perioperative care

Steroids (Statement 7)Strong recommendation

Antibiotics (Statement 8)Strong recommendation against Postoperative care

Pain control (Statement 9)

Recommendation Posttonsillectomy hemorrhage (Statement 10)

Recommendation

S8 Otolaryngology–Head and Neck Surgery 144(1S)

with a history of recurrent severe infections requiring hospi-talization, complications of infection such as peritonsillar abscess or Lemierre syndrome (thrombophlebitis of the inter-nal jugular vein), or a family history of rheumatic heart disease or numerous repeat infections in a single household (“ping-pong spread”) may reasonably be considered for the procedure. However, caregivers should be educated on the likelihood of spontaneous improvement and the magnitude of benefit con-ferred by tonsillectomy for 2 years after surgery.

History greater than 12 months. Observation of frequent pharyngotonsillitis beyond 1 year may be indicated even in patients meeting the Paradise criteria. In several randomized controlled trials, the control group (nontonsillectomized) demonstrated a trend toward spontaneous improvement during the follow-up period, often with patients no longer meeting the original criteria for study entry. In a randomized controlled study of patients who met the Paradise criteria, children in the control group experienced only an average of 1.17 episodes of throat infection annually in the following first year, 1.03 in the second year, and 0.45 episodes in the third year.31Results were corroborated in another study that relaxed the Paradise criteria but still required more than 3 episodes of recurrent pharyngotonsillitis per year for enrollment.20 As in the first study, control groups had a mean rate of throat infections of 0.43, 0.31, and 0.16 in years 1, 2, and 3. A third study with entrance criteria that were less stringent than the Paradise cri-teria found that the control group had an average of 0.77 throat infections during the 22-month follow-up.67

A Cochrane review on the efficacy of tonsillectomy for recurrent tonsillitis concludes that some cases may resolve without surgery.68 Another systematic review of randomized controlled trials found that the rate of sore throat in the control group was on average 0.3 episodes per month.69 Confirming earlier work,70 the authors reported that in all studies, the con-trol group showed a spontaneous reduction of rates of recurrent infection.69

Additional information regarding the natural history of recurrent pharyngotonsillitis is found in case series describing outcomes for patients awaiting tonsillectomy. Although most still had indications for surgery, a significant proportion did not. One study of children awaiting tonsillectomy for a history of 5 episodes over a 2-year period found that over a mean waiting period of 9 months, 27% no longer met criteria for surgery.71 Another study of 623 children found that 18.6% of children placed on a waiting list for a mean of 10.8 months after meeting the Paradise criteria had no episodes of recurrent pharyngotonsillitis within the 6 months before the scheduled procedure.72 A third study of 257 children selected for tonsil-lectomy based on a history of 4 to 6 episodes for 2 consecutive years but placed on a waiting list reached similar conclu-sions.73 Twelve months after waiting list placement, 40% had 3 or fewer episodes of tonsillitis in the preceding 6 months, and 36 months after waiting list placement, 65% had 3 or fewer episodes of tonsillitis in the preceding 6 months. Two other studies reported that 20% to 50% of individuals no longer needed surgery.74,75

Patients and caregivers should be educated on the limited benefits of tonsillectomy when performed in less severely affected children and adolescents. Potential surgical compli-cations should be discussed so patients and caregivers may weigh the risks and benefits. Prompt medical treatment should be implemented when indicated in cases of pharyngitis caused by Group A b-hemolytic streptococcus (GABHS). Evidence Profile for Statement 1:W atchful Waiting for Recurrent Tonsillitis

?Aggregate evidence quality: Grade B, randomized controlled trials with minor limitations that fail to

show clinically important advantages of surgery over

observation alone (as stated in Statement 1), and

Grade C, observational studies showing improve-

ment with watchful waiting

T able 5. Paradise Criteria for T onsillectomy31

Criterion Definition Minimum frequency of sore throat episodes7 or more episodes in the preceding year, OR

5 or more episodes in each of the preceding 2 y, OR

3 or more episodes in each of the preceding 3 y

Clinical features (sore throat plus the presence of one or more qualifies as a counting episode)T emperature > 38.3°C, OR

Cervical lymphadenopathy (tender lymph nodes or >2 cm), OR T onsillar exudate, OR

Positive culture for group A b-hemolytic streptococcus

T reatment Antibiotics had been administered in conventional dosage for proved or suspected

streptococcal episodes

Documentation Each episode and its qualifying features had been substantiated by

contemporaneous notation in a clinical record, OR

If not fully documented, subsequent observance by the clinician of 2 episodes of

throat infection with patterns of frequency and clinical features consistent with

the initial history a

a This last statement allows children who meet all other criteria for tonsillectomy except documentation to nonetheless qualify for surgery if the same pattern of reported illness is observed and documented by the clinician in 2 subsequent episodes. Because of this tendency to improve with time, a 12-month period of observation is usually recommended prior to consideration of tonsillectomy as an intervention.

Baugh et al S9

?Benefit: Avoid unnecessary surgery with potential complications of vomiting, hemorrhage, pain, infec-

tion, or anesthesia problems

?Harm: Waiting may result in delayed treatment in patients who have unusually frequent and severe

recurrent throat infections

?Cost: Potential direct cost of managing future throat infections

?Benefits-harm assessment: Preponderance of benefit over harm

?Value judgments: Panel consensus that tonsillectomy for recurrent throat infection should be limited to cir-

cumstances for which clinically important benefits

are shown in randomized controlled trials; emphasis

on avoiding harm related to surgery or anesthesia in

a condition that may be largely self-limited

?Role of patient preferences: Limited to specific unusual circumstances such as complications of ton-

sillitis or comorbidities

?Intentional vagueness: None

?Exclusions: Patients with peritonsillar abscess, per-sonal or family history of rheumatic heart disease,

Lemierre syndrome, or severe infections requiring

hospitalization

?Policy level: Recommendation

STATEMENT 2. RECURRENT THROAT INFECTION WITH DOCUMENTATION: Clinicians may recommend tonsillectomy for recurrent throat infection with a fre-quency of at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years with documentation in the medical record for each episode of sore throat and one or more of the follow-ing: temperature >38.3°C, cervical adenopathy, tonsillar exudate, or positive test for GABHS.Option based on sys-tematic reviews and randomized controlled trials with minor limitations, with a balance between benefit and harm. Supporting Text

The purpose of this statement is to ensure that patients with recurrent throat infection who are selected for tonsillectomy have a severity of illness (T able 5) consistent with descriptions of disease found in well-designed clinical trials. Despite the abundance of randomized controlled trials on tonsillectomy, there are few published investigations of its efficacy or effective-ness for sore throat, and many are outdated or lacking in scientific design or validity. The preponderance of evidence suggests that in the most severely and frequently affected children, tonsillec-tomy results in a modest degree of improvement.

Defining and documenting “throat infection.”Patients referred for tonsillectomy are rarely evaluated by the surgeon during an acute episode of throat infection. It is therefore incumbent upon the referring clinician to accurately describe an individ-ual episode of throat infection and to document the frequency of these events.

The presence of sore throat was a necessary entrance crite-rion in all randomized controlled trials of tonsillectomy for infection. As a result, no claim can be made that tonsillectomy is effective in those children who present with a constellation of symptoms that does not include sore throat, even when GABHS is identified. The presence of tonsillar inflammation was not a necessary criterion, and absence of tonsillar inflam-mation in given patients does not detract from the applicability of this statement.

When a child is evaluated for sore throat, the examining clinician should record a subjective assessment of the patient’s severity of illness; physical findings including body tempera-ture, pharyngeal and/or tonsillar erythema, tonsil size, tonsillar exudate, cervical adenopathy (presence, size, and tenderness); and the results of microbiologic testing for GABHS. In chil-dren with recurrent sore throat whose tests for GABHS are repeatedly positive, it may be desirable to rule out streptococ-cal carriage concurrent with viral infection as carriers are unlikely to transmit GABHS or to develop suppurative com-plications or nonsuppurative sequelae of the disease such as acute rheumatic fever.76,77 Supportive documentation in chil-dren who meet criteria for tonsillectomy may include absence from school, spread of infection within the family, and a family history of rheumatic heart disease or glomerulonephri-tis. The referring clinician should furnish the consultant with a summary of the documentation to aid in the medical decision making regarding potential surgical intervention.

Many caregivers may choose not to visit a medical facility for every throat infection, and therefore documentation of events may be lacking. Studies suggest that patients whose events are less severe or well documented do not gain suffi-cient benefit from tonsillectomy to justify the risk and morbidity of the procedure.20 In such patients, tonsillectomy should not be performed immediately; instead, clinicians should initiate an active period of observation during which documentation of additional events may be made.

Efficacy and effectiveness of tonsillectomy for recurrent throat infection.Most clinical trials investigating the efficacy of ton-sillectomy20,31,67have a high risk of bias because of poorly defined entrance criteria, nonrandom selection of operated subjects, exclusion of severely affected patients, or reliance on caregivers for postoperative data collection. However, those studies67,68 in which these factors were minimized suggest a modest but statistically significant reduction in frequency of throat infection among severely affected patients undergoing tonsillectomy, while less severely affected individuals appear less likely to benefit from the procedure.

In the most frequently cited and meticulous trial, Paradise and colleagues31included patients only if their episodes of throat infection met strict criteria outlined in T able 5. One of the most important criterion was that each episode and its qualifying features had been substantiated by contemporane-ous notation in a clinical record. Adherence to the advice earlier in this section may facilitate that goal, but some chil-dren are likely to remain who would otherwise qualify for tonsillectomy but lack appropriate documentation. Paradise and coworkers31 also recognized this possibility and therefore allowed children who met all other criteria for tonsillectomy except documentation to nonetheless qualify for surgery if

S10 Otolaryngology–Head and Neck Surgery 144(1S)

the same pattern of reported illness was prospectively docu-mented in 2 subsequent episodes. For example, if there had been a history of 5 episodes in each of the 2 preceding years, 2 episodes would have had to be observed within 2/5 year, or within 146 days. Therefore, patients with undocumented his-tories of severe recurrent sore throat may still be offered surgery provided they continue to suffer severe sore throats with similar frequency after an additional period of observa-tion and documentation. The following study results were obtained:

?Considering sore throats of any degree of severity, the tonsillectomy group experienced a mean rate

reduction of 1.9 episodes per year in the first year of

follow-up; although this difference was statistically

significant, the sore throat associated with perfor-

mance of the surgery (which would otherwise count

as 1 episode) was excluded from the data. In the con-

trol group, patients also improved compared with

their pre-enrollment frequency of infection, experi-

encing a mean of only 3.1 annual events. Group

differences were no longer significant in the third

year of follow-up.

?For episodes of moderate or severe throat infection, the control group experienced 1.2 episodes compared

with 0.1 in the surgical group. The rate reductions

diminished over the subsequent 1 years of follow-up

and were not significant in the third year.

?Mean days with sore throat in the first 12 months were not statistically different between the 2 groups

but included a predictable period of sore throat post-

operatively. Some patients from the control group,

however, opted for surgery during the follow-up

period, perhaps leading to underestimation of the

effect of surgery. In addition, the distribution of

patients by frequency of throat infection was statisti-

cally different between the surgical and nonsurgical

groups; the effect of this factor on the final results is

uncertain.

In a subsequent study by the same authors,20 the entrance criteria for history and/or documentation of throat infection were relaxed with less stringent criteria for the number of episodes, clinical features required, and need for concurrent documentation (ie, 4-6 episodes in the past year or 3-4 episodes per year in the past 2 years). For example, children could qualify for surgery if an episode of tonsillitis was partially documented or even not documented provided that the study team observed 1 subsequent episode of tonsillitis in the 4 months after the initial evaluation. In the 2 arms of the study (tonsillectomy and adenotonsillectomy vs control, and adenotonsillectomy vs control), patients undergoing surgery experienced rate reductions of 0.8 and 1.7 episodes/y, respectively, in the first year. For episodes of moderate or severe sore throat, control subjects in the 2 arms of the study combined experienced 0.3 episodes/y overall compared with 0.1/y in subjects undergoing surgery. Mean days with sore throat in the first 12 months were not statistically different in either arm of the study. A lthough some benefits of tonsillectomy remained statistically significant over 3 years, the investigators suggested that the modest benefit conferred by tonsillectomy in children moderately affected with recurrent throat infection did not justify the inherent risks, morbidity, and cost of the surgery.

A randomized controlled trial comparing tonsillectomy with watchful waiting in children aged 2 to 8 years examined fever >38.0°C for at least 1 day as the primary outcome mea-sure.67 Children were selected for tonsillectomy “according to current medical practice”; however, patients meeting Paradise criteria were specifically excluded, thus selecting a less severely affected population. During a mean follow-up of 22 months, children in the tonsillectomy group had 0.2 fewer epi-sodes of fever per person-year, and from 6 to 24 months there was no difference between the groups. The surgical group also demonstrated, per person-year, mild reductions in throat infec-tions (0.2), sore throats (0.6), days with sore throat (5.9), and upper respiratory tract infections (0.5). Absence from day care or school due to upper tract respiratory infections was compa-rable between the groups (difference 0.1).

Pooled data from these studies were also analyzed in a Cochrane systematic review.68Patients undergoing tonsillec-tomy experienced 1.4 fewer episodes of sore throat in the first year compared with the control group; however, the cost of this reduction was 1.0 episode of sore throat in the immediate post-operative period. When only episodes of moderate/severe sore throats were considered, surgery was associated with just 0.2 fewer episodes in exchange for the episode of sore throat in the immediate postoperative period. The number of sore throat days was about 4 days less in the surgical group (21 vs 17).

Another systematic review69 reported an odds ratio of 0.57 favoring tonsillectomy, suggesting a 43% overall reduction in sore throat events. The number needed to treat with tonsillec-tomy to prevent 1 sore throat per month for the first year after surgery was 11. A final systematic review that included 13 randomized controlled trials and nonrandomized controlled studies on the efficacy of tonsillectomy in children70 reported pooled estimated risk differences favoring tonsillectomy over observation of 1.2 fewer episodes of sore throat, 2.8 fewer days of school absence, and 0.5 fewer episodes of upper respi-ratory infection per person-year. Both of the reviews just described also found that, in all of the trials studied, the con-trol group showed a significant spontaneous reduction in the rate of recurrent infection.69,70Furthermore, in most case series describing outcomes for patients on tonsillectomy wait lists, indications for surgery were no longer present in a size-able proportion of patients with mean follow-up periods of up to 3 years.71-75,78

Despite the modest advantages conferred by tonsillectomy for sore throat, studies of QoL all suggest a significant improvement in patients undergoing the procedure. Only 2 of these studies enrolled children exclusively,4,79and both reported increased scores in nearly all subscales. However, both also had numerous methodological flaws such as inclu-sion of patients with chronic tonsillitis without definition

Baugh et al S11

based on signs and symptoms, absence of a control group, low response rates with potential selection bias, poor follow-up, and caregiver collection of data. Additional QoL studies that avoid these problems would be useful for clinical decision making.

Balance of benefit versus harm for tonsillectomy in severe recur-rent throat infection. Families of patients who meet the appropriate criteria for tonsillectomy as described above should be advised of the modest anticipated benefits of tonsil-lectomy weighed against the natural history of resolution and the risk of surgical morbidity and complications. The harm and adverse events of tonsillectomy are not trivial and have been fully described earlier in this guideline under the section titled “Health Care Burden.” In considering the potential harms, in aggregate, the guideline panel agreed there was not a clear preponderance of benefit over harm for tonsillectomy, even for children meeting the strict criteria in the first study by Paradise et al.31 Instead, there was felt to be a balance that still allows tonsillectomy as an appropriate management option for these children but does not imply that all qualifying children should have surgery.

The role of tonsillectomy as an option in managing chil-dren with recurrent throat infection means there is a substantial role for shared decision making with the child’s caregiver and primary care clinician. Moreover, decisions may be influ-enced by modifying factors, described in the next section, that may favor surgical intervention over observation. When-ever there is doubt or hesitation about the appropriateness of surgery, even if the criteria in T able 5 are fulfilled, a consul-tation with an otolaryngologist and a period of watchful waiting to confirm persistence of a problem should be considered.

Limitations of the available randomized controlled trials must also be considered when assessing the benefits versus harms of surgery. In their first study, Paradise and colleagues31 randomized 91 children to surgery versus observation, but they screened thousands of study candidates to arrive at this sample. Only a small percentage of the initial cohort met the strict entry criteria (T able 5), and only about half of eligible children had parents who agreed to randomization. This was less of a problem in the second study by these investigators,20 in which most eligible children were enrolled. In both stud-ies, however, only about half (46%-62%) of enrolled children completed all 3 years of follow-up. The panel did not con-sider these limitations sufficient to invalidate the studies, the same conclusion reached in a Cochrane review,68but did downgrade the aggregate evidence level from A (randomized trials) to B (randomized trials with limitations) to reflect this situation.

Evidence Profile for Statement 2:Recurrent Infection With Documentation

?Aggregate evidence quality: Grade B, well-designed randomized controlled trials with minor limitations;

some Grade C observational studies

?Benefit: Modest reduction in the frequency and severity of recurrent throat infection for up to 2 years

after surgery; modest reduction in frequency of group

A streptococcal infection for up to 2 years after sur-

gery; improved disease-specific QoL

?Harm: Risk and morbidity of tonsillectomy in patients appropriately selected for the procedure,

including, but not limited to, persistence of throat

infection, pain, and missed activity after surgery,

hemorrhage, dehydration, injury, and anesthetic

complications

?Cost: Direct cost of tonsillectomy; direct nonsurgical costs (antibiotics, clinician visit) and indirect costs

(caregiver time, time missed from school) associated

with recurrent infection

?Benefits-harm assessment: Balance between benefit and harm

?Value judgments: Importance of balancing the modest, short-term benefits of tonsillectomy in care-

fully selected children with recurrent throat infection

against the favorable natural history seen in control

groups and the potential for harm or adverse events,

which, although infrequent, may be severe or

life-threatening

?Role of patient preferences: Large role for shared decision making in severely affected patients, given

favorable natural history of recurrent throat infec-

tions and modest improvement associated with

surgery; limited role in patients who do not meet

strict indications for surgery

?Intentional vagueness: None

?Exclusions: None

?Policy level: Option

STATEMENT 3. TONSILLECTOMY FOR RECUR-RENT INFECTION WITH MODIFYING FACTORS: Clinicians should assess the child with recurrent throat infection who does not meet criteria in Statement 2 for modifying factors that may nonetheless favor tonsillec-tomy, which may include but are not limited to multiple antibiotic allergy/intolerance, PFAPA (periodic fever, aph-thous stomatitis, pharyngitis, and adenitis), or history of peritonsillar abscess. Recommendation based on randomized controlled trials and observational studies with a preponder-ance of benefit over harm.

Supporting Text

Modifying factors, which can lead to significant morbidity, may be especially important in situations for which, in gen-eral, the benefits and risks of surgery are closely matched but compelling individual features (such as excessive mor-bidity) may nonetheless warrant tonsillectomy. Modifying factors are defined within 3 categories: (1) exceptions to recognized criteria based on individual features of illness such as multiple antibiotic allergies, (2) specific clinical syndromes such as PFAPA or recurrent tonsillitis associ-ated with peritonsillar abscess, and (3) poorly validated clinical indications (eg, halitosis, febrile seizures, and malocclusion).

S12 Otolaryngology–Head and Neck Surgery 144(1S)

With regard to category 1, tonsillectomy is efficacious in reducing the number and severity of subsequent infections for at least 2 years when children fulfill stringent criteria for recurrent sore throat (T able 5).31For children with a lesser degree of illness, however, the pattern of illness may influence a recommendation for tonsillectomy. For example, when sore throat episodes are very severe or tolerated poorly by the child, or if the child has extensive drug allergies making antimicrobial therapy selection difficult, or if illness-related absences inter-fere with school performance, then surgery with its attendant reduction of episodes of illness may be recommended.

With regard to the second category of specific clinical syn-dromes, PFAPA and recurrent peritonsillar abscess may be indications for tonsillectomy. PFAPA is now a well-recognized syndrome occurring primarily in children younger than 5 years of age. The illness (which does not usually last more than 5 days) recurs (at least 3 documented episodes) at regular intervals of 3 to 6 weeks and is characterized by the sudden onset of fever, pharyngitis plus tender cervical lymphadenop-athy, or aphthous ulcers.80 While the use of steroids usually leads to prompt termination of an episode, the interval between episodes shortens.80 Other potential therapies such as cimeti-dine may be helpful. Two small, randomized controlled trials demonstrated that tonsillectomy was effective for treating PFAPA syndrome, but children in the control groups also showed improvement.81,82 Tonsillectomy may be considered based on the frequency of illness, severity of infection, and the child’s response to medical management.

The role of tonsillectomy in managing peritonsillar abscess remains controversial, but the threshold for surgery is lowered when a child with recurrent throat infection develops, or has a past history of, peritonsillar abscess.83 When peritonsillar abscess is treated with needle aspiration or incision and drainage, the need for subsequent tonsillectomy is about 10% to 20%.84,85 This rate may not merit routine tonsillectomy unless a patient also has a history of frequent prior throat infections, especially when a culture is positive for GABHS. Some authors advocate “quinsy” tonsillectomy when the abscess is present, especially if general anesthesia is required for drainage (eg, uncooperative child) and there is a prior history of tonsil disease.85

Tonsillectomy has been recommended for treating pediat-ric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS), but evidence is anecdotal and the entity is poorly understood.86 The role of tonsillec-tomy in managing PANDAS is uncertain and unproved.

The last category contains a series of poorly validated indi-cations for tonsillectomy that have not been tested in any controlled trials or case series, including chronic tonsillitis, febrile seizures, muffled (“hot potato”) speech, halitosis, mal-occlusion of teeth, tonsillar hypertrophy, cryptic tonsils, or chronic pharyngeal carriage of GABHS. There is a substantial role for shared decision making with caregivers when consid-ering tonsillectomy for 1 or more of these conditions, with individualized decisions that take into account severity of ill-ness and QoL. Any potential benefits of tonsillectomy for these conditions must be balanced against the attendant risks of surgery.Evidence Profile for Statement 3:T onsillectomy for Recurrent Infection With Modifying Factors

?Aggregate evidence quality: Grade B, randomized controlled trials with limitations, for PFAPA; Grade

C, observational studies for all other factors ?Benefit: Identifying factors that might otherwise have been overlooked, which may influence the deci-

sion to perform tonsillectomy and ultimately improve

patient outcomes

?Harm: None

?Cost: None

?Benefits-harm assessment: Preponderance of benefit over harm

?Value judgments: None

?Role of patient preferences: Should be included

?Intentional vagueness: None

?Exclusions: None

?Policy level: Recommendation

STATEMENT 4. TONSILLECTOMY FOR SLEEP- DISORDERED BREATHING: Clinicians should ask caregivers of children with sleep-disordered breathing and tonsil hypertrophy about comorbid conditions that might improve after tonsillectomy, including growth retardation, poor school performance, enuresis, and behavioral problems. Recommendation based on observational before-and-after studies with a preponderance of benefit over harm. Supporting Text

The purpose of this statement is to: (1) help clinicians and caregivers make informed decisions about tonsillectomy in children with clinically diagnosed SDB and (2) highlight the importance of eliciting a history about modifying factors that affect the decision to proceed with surgery. Although PSG is the gold standard for diagnosing SDB in children, it is unnec-essary (or not necessary) to perform in every case and does not establish the effects of the sleep disorder on the child’s well-being. The initial approach to a child with suspected SDB should include an assessment of these factors (behavioral problems, poor school performance, decreased QoL, failure to thrive, and enuresis) by history and physical examination. Failure to identify such factors may lead to suboptimal care with an inability to address the underlying problem.

SDB is characterized by recurrent partial or complete upper airway obstruction during sleep, resulting in disruption of normal ventilation and sleep patterns.87 The diagnosis of SDB in children may be based on history, physical examination, audio/video taping, pulse oximetry, or limited or full-night PSG. History and physical examination are the most common initial methods for diagnosis. The presence or absence of snor-ing neither includes nor excludes SDB, as not all children who snore have SDB, and caregivers may not observe intermittent snoring that occurs during the night.88 Although caregivers often describe their children as having excessive daytime sleepiness, this seems to be less of a problem in children than adults. Children with SDB display sleepiness scores that are

Baugh et al S13

within the normal range for adults. However, they are higher than controls, and primary snorers exhibit similar scores to those of children with OSA.89

Tonsillar and adenoid hypertrophy is recognized as the most common cause of SDB in children. Tonsil size is readily identified using a tonsil grading scale (T able 6),90 with tonsil-lar hypertrophy defined as grades 3+ or 4+. Tonsillar size alone does not correlate with the severity of SDB,91 although the combined volume of the tonsils and adenoids more closely correlate with SDB severity.92,93 It is likely that the severity of SDB is related to a combination of tonsillar and ade-noid hypertrophy, craniofacial anatomy, and neuromuscular tone. For example, tonsils that are only 1+ or 2+ in size may nonetheless contribute to airway obstruction in healthy chil-dren and especially those with hypotonia or craniofacial anomalies.94

SDB is known to increase the risk for externalizing (eg, aggression, hyperactivity) and internalizing behaviors (eg, depression) in some children, leading to symptoms of atten-tion-deficit hyperactivity disorder.8,95,96Problems with memory and attention, often associated with SDB, may lead to poor school performance.97 Studies have found that the QoL in children with SDB is worse than that of controls. For exam-ple, in one study, the QoL of children with SDB was similar to, or worse than, that of children with chronic diseases such as asthma or juvenile rheumatoid arthritis.98It is therefore important to view SDB as a condition that can dramatically affect the well-being of the child, family, and the primary caregiver.

Several studies have shown that up to 50% of children with SDB have enuresis.99-103 Since enuresis can be embarrassing for the child and family, its presence may not be mentioned during routine evaluations. The primary care physician and the caregiver may also not be aware of an association between SDB and enuresis. SDB can also lead to failure to thrive and should be considered in children evaluated for growth fail-ure.104 It remains unknown whether growth failure is a result of hormonal changes caused by SDB or simply excessive energy expenditures to overcome the airway obstruction. Con-sequently, a child with mild SDB may have significant behavioral problems, poor school performance, reduced QoL, enuresis, and growth failure that may equally contribute to the decision to proceed with tonsillectomy.

Several studies have shown improvement or resolution of these modifying factors following tonsillectomy for SDB in children. Behavioral and neurocognitive problems have been shown to improve significantly after tonsillectomy for SDB by both objective95,96 and subjective testing.105 This improve-ment in behavior has been shown to continue for at least 2 years after tonsillectomy.8 School performance has also been shown to improve significantly in children with SDB follow-ing tonsillectomy as compared with those who do not undergo surgical intervention.97 There is also a dramatic improvement in QoL in children after tonsillectomy for SDB,10,11,98 and this improvement is maintained for up to 2 years after surgery.98 Enuresis has been shown to resolve or improve in most children with SDB after tonsillectomy. One study showed that 61% of children were free of enuresis and 23% had a decrease in enuresis after surgical therapy for SDB.28 Other studies that have followed children beyond 1 year have reported similar results, with the resolution rate increasing proportionally as the time following surgery increases.102,103 A systematic review and meta-analysis of studies that evaluated height and weight changes after tonsillectomy for SDB104 reported that height, weight, and growth biomarkers increased significantly after tonsillectomy, concluding that SDB, secondary to tonsil and adenoid hypertrophy, should be considered when screen-ing, treating, and referring children with growth failure.

These modifying factors, however, do not affect every child with SDB to the same degree. For example, only 30% to 40% of children with SDB proven by PSG score in the abnor-mal range for hyperactivity,105and an unknown, but very small percentage, have growth failure. Equally, the severity of SDB does not correlate closely with the severity of behav-ioral or QoL scores.105,106 Similar reports show a significant difference in prevalence of enuresis in children with an apnea-hypopnea index (AHI) >1 compared with children with an AHI <1.100 However, there was no significant difference in the prevalence of enuresis in children with an AHI 1 of 5, 5 to 15, or >15.

Behavioral problems, decreased school performance, decreased QoL, enuresis, and growth failure may have a wide range of causes that includes but is not limited to SDB. There-fore, the clinician should be aware of the association between SDB and these modifying factors, recognizing that the sleep disorder may contribute to but not be the sole cause of the problem. Nevertheless, the clinician evaluating a child pri-marily for one of these modifying factors should elicit an adequate sleep history.

Tonsillar asymmetry can be seen in children and may have an effect on the decision to proceed with tonsillectomy. Ton-sillar asymmetry can lead to concern as it may suggest the presence of a tumor, specifically lymphoma, in the larger tonsil. Careful assessment of the patient with tonsillar asym-metry is necessary to determine if a lymphoma is present. This would include a history, physical examination, and appropri-ate lab testing. However, in isolation, the presence of tonsillar asymmetry alone is not an indication for tonsillectomy.107-109 To date, most outcomes data on the efficacy of tonsillec-tomy and adenoidectomy for SDB in children have been based

T able 6. Gradation of T onsillar Enlargement90

Grade Definition Description

0Not visible T onsils do not reach tonsillar pillars

1+Less than 25%T onsils fill less than 25% of the transverse

oropharyngeal space measured

between the anterior tonsillar pillars

2+25% to 49%T onsils fill less than 50% of the

transverse oropharyngeal space

3+50%-74%T onsils fill less than 75% of the

transverse oropharyngeal space

4+75% or more T onsils fill 75% or more than the

transverse oropharyngeal space

S14 Otolaryngology–Head and Neck Surgery 144(1S)

on observational studies110,111and systematic reviews of observational studies.32,33 Few studies have randomized chil-dren to an intervention and control group. These studies have shown an association between tonsillectomy and improved outcomes in children with SDB. Furthermore, most studies have reported on a single outcome measure such as behavior or QoL. In the future, prospective randomized controlled stud-ies using multidimensional outcome measures are needed to determine if tonsillectomy with adenoidectomy, versus non-surgical intervention, causes significant improvement in outcomes, and if so, the magnitude of these improvements. Evidence Profile for Statement 4:T onsillectomy for Sleep-Disordered Breathing

?Aggregate evidence quality: Grade C, before-and-after observational studies

?Benefit: To improve decision making in children with SDB by identifying comorbid conditions asso-

ciated with SDB, which might otherwise have been

overlooked, and may improve after tonsillectomy ?Harm: None

?Cost: None

?Benefits-harm assessment: Preponderance of benefit over harm

?Value judgments: Perception that potentially impor-tant comorbid conditions may be overlooked or not

included in routine assessment of children with SDB,

even though they may improve after intervention;

consensus that substantial evidence from before-and-

after studies supports inquiring about these

conditions, despite an absence of randomized con-

trolled trials supporting a recommendation for or

against tonsillectomy

?Role of patient preferences: Large role for caregiver education and shared decision making

?Intentional vagueness: None

?Exclusions: None

?Policy level: Recommendation

STATEMENT 5. TONSILLECTOMY AND POLYSOM-NOGRAPHY: Clinicians should counsel caregivers about tonsillectomy as a means to improve health in children with abnormal polysomnography who also have tonsil hypertro-phy and sleep-disordered breathing. Recommendation based on observational before-and-after studies with a preponderance of benefit over harm.

Supporting Text

The purpose of this statement is to guide the clinician in making decisions about tonsillectomy in a child with hyper-trophy of the tonsils who has already had PSG and the test is interpreted as “abnormal” by the sleep laboratory. This section will not discuss indications for PSG, nor will the definition of what is “normal” versus “abnormal” be considered since there is limited consensus and this topic is beyond the scope of this guideline. Although the guideline panel recognizes that children do not routinely need PSG before tonsillectomy, for some children who present for surgical consideration, a PSG has already been obtained, and the clinician therefore needs to incorporate the result into decision making.

Overnight PSG is recognized as the most reliable and objective test to assess the presence and severity of OSA.112 Consensus-based guidelines for performing PSG in children were established by the American Thoracic Society, and nor-mative data in children have been reported in numerous studies.13,113,114 Whereas standardized criteria for interpreting PSG in children are lacking, a consensus has emerged that the adult OSA criteria are not applicable to children. Most sleep specialists consider PSG in a child to be abnormal if there are pulse oximetry levels less than 92% or an AHI >1 (greater than 1 apneic or hypopneic event in 2 or more consecutive breaths per hour) or both.115 Furthermore, an AHI >5 is con-sidered by many to warrant tonsillectomy.116There is no evidence-based cutoff value, however, to indicate the need for tonsillectomy in children, and some children with AHI <5 may still be symptomatic and require intervention.117,118 Clinicians with expertise in pediatric respiratory and sleep disorders are needed to accurately interpret PSGs in children. Sleep centers may use different scoring criteria in defining OSA in children reflecting the lack of consensus of the defini-tion.119 Care should be taken when comparing sleep studies from different sleep laboratories as controversy exists sur-rounding which respiratory events in children are significant enough to be recorded. Some authors have advocated the use of respiratory disturbance index (RDI) instead of AHI to score and report abnormal airflow that could lead to clinical symp-toms in children.117,118 The scoring and reporting of RDI helps to identify abnormal breathing events that are less dramatic than apnea and hypopnea but are significant enough to cause arousal and sleep fragmentation. Any decision to recommend tonsillectomy should not be based solely on PSG findings but should be based on clinical history, examination, and the like-lihood that adenotonsillectomy will improve the sleep-related breathing issues.

The measure of oxygenation by pulse oximetry is standard for PSG. Hypoxemia and repetitive oxygen desaturation can be frequent in children with SDB. Children may have signifi-cant oxygen desaturation (<85%) yet have a low apnea index or AHI.120 There is also evidence that even mild oxygen desat-uration can negatively affect academic performance.27 Therefore, the interpretation of oxygen desaturation levels is as important as the AHI in assessing the severity of OSA. Oxygen saturation <85% is clearly abnormal, and treatment should be recommended. However, mild desaturation (<92%) may still be clinically relevant in the presence of high suspi-cion of SDB based on clinical examination and history.

While there are no randomized controlled trials comparing tonsillectomy to other interventions for children with SDB, favorable short-term outcomes have been reported extensively in nonrandomized studies. Tonsillectomy for the indication of SDB significantly improves QoL based on validated question-naires measuring sleep disturbance, physical symptoms, emotional symptoms, hyperactivity, and daytime function-ing.9-12,95Similarly, pulmonary hypertension has normalized

Baugh et al S15

after tonsillectomy based on echocardiography assessment121; school performance has improved26,97; health care utilization has been reduced122; and sleep parameters have improved as demonstrated by PSG.32,33 Despite the documented improve-ment, PSG is often not normalized, and many children either continue to have residual symptoms of SDB and remain symp-tomatic or have recurrence of symptoms.32,33,110,123-126Risk factors for persistent or recurrent OSA include severe preop-erative OSA, obesity, children with craniofacial and neuromuscular anomalies, positive family history of OSA, and African American ethnicity.32,110,123-126

Tonsillectomy is typically performed in an outpatient set-ting. Children with complicated medical histories including cardiac complications of OSA, neuromuscular disorders, pre-maturity, obesity, failure to thrive, craniofacial anomalies, or recent respiratory infection should be treated in an inpatient set-ting.112 Obesity increases the postoperative risk of respiratory complications in SDB with an overall odds ratio of 7.13; there-fore, overnight hospitalization may be recommended.127 SDB severity is a risk factor for postoperative respiratory complica-tions128-131and is therefore an indication for postoperative admission for children.116,128The level of desaturation corre-lates with the number of obstructive events, thereby reflecting a higher AHI.128,132 Although there is no general consensus in defining the level of severity of SDB in children based on AHI, the American Society of Anesthesiologists guideline defines severe OSA as AHI >10.133 Young children with SDB also have been shown to have higher risk of postoperative airway compli-cations,134-136 and hospitalization is generally recommended for children less than 3 years of age.112,116

Evidence Profile for Statement 5:T onsillectomy and Polysomnography

?Aggregate evidence quality: Grade C, observational, before-and-after studies and meta-analysis of obser-

vational studies showing substantial reduction in the

prevalence of SDB and abnormal PSG after

tonsillectomy

?Benefit: Improved caregiver awareness of how tonsil-lectomy may benefit their child when PSG is abnormal,

including improved sleep, better nighttime and day-

time functioning, improved functional health status,

and prevention or improvement of comorbid condi-

tions, including growth retardation, poor school

performance, enuresis, and behavioral problems ?Harm: Potential anxiety to caregivers from counseling

?Cost: None

?Benefits-harm assessment: Preponderance of benefit over harm

?Value judgments: Panel consensus that objectively documented SDB with PSG may warrant interven-

tion, even if not associated with comorbid conditions;

recognition that abnormal PSG results encompass a

broad range of values, with lack of evidence to sup-

port definitions of severity that correlate with surgical

outcomes; concern that not treating children with

abnormal PSG may lead to future morbidity or

impaired health status

?Role of patient preferences: Moderate; different caregivers may seek different levels of information

and detail

?Intentional vagueness: The panel uses the term abnormal PSG recognizing there is no consensus

among clinicians, institutions, or disciplines regard-

ing the exact criteria that define an abnormal study.

The panel agreed that indications for PSG are an

important area for clarification, but it was deemed

beyond the guideline scope and excluded from

discussion

?Exclusions: None for counseling

?Policy level: Recommendation

STATEMENT 6. OUTCOME ASSESSMENT FOR SLEEP-DISORDERED BREATHING: Clinicians should counsel caregivers and explain that SDB may persist or recur after tonsillectomy and may require further man-agement. Recommendation based on observational studies, case-control and cohort design, with a preponderance of benefit over harm.

Supporting Text

The purpose of this statement is to emphasize that SDB may persist after tonsillectomy, despite perceptions by caregivers and clinicians that surgery is curative. As a result, clinicians should counsel, or educate, caregivers of patients who may require further management (T able 7). Counseling may be accomplished by either (1) discussing briefly the reasons why SDB may persist or recur after tonsillectomy and require fur-ther management or (2) providing an informational brochure or summary handout. The method of counseling should be documented in the medical record.

Children with SDB may have other underlying medical conditions, such as obesity, which contribute to their symp-toms and persist after tonsillectomy. PSG is considered the gold standard for evaluating patients with suspected SDB and is also the most reliable outcome measure for treatment evalu-ation. PSG may be difficult to obtain because of limited availability and restrictions in coverage by insurers or third-party payers.

Observational studies show that tonsillectomy has a vari-able effect on resolving SDB as measured by PSG; however, less than 10% of children undergo preoperative PSG, and an even smaller percentage undergo postoperative studies.8A recent meta-analysis32reported an improvement in SDB in most children but a resolution in only 60% to 70% of subjects. The percentage of children in whom SDB has resolved is also dependent on the proportion of children, in the study popula-tion, who are overweight or obese. In a meta-analysis of 4 studies, resolution of SDB in obese children after tonsillec-tomy occurred in 10% to 25% of patients.137 This is in contrast to a reported resolution of SDB in 70% to 80% of normal weight children.111

S16 Otolaryngology–Head and Neck Surgery 144(1S)

When children have tonsillectomy for specific comorbid conditions related to SDB (eg, growth retardation, poor school performance, enuresis, or behavioral problems), the SDB is often considered cured when the caregiver reports symptom resolution after surgery. In this situation, a postop-erative PSG would generally be unnecessary, unless the symptoms later relapsed. Postoperative caregiver report of continuing symptoms is a good indicator of persistent SDB34 and indicates the need for further evaluation, including PSG. Conversely, the severity of SDB preoperatively correlates poorly with severity of behavioral14 or QoL10 parameters, and resolution of SDB also does not correlate well with improve-ments in behavior.14Significant improvements in behavior and QoL have been reported regardless of the preoperative severity of SDB.34,106

Evidence Profile for Statement 6:Outcome Assessment for Sleep-Disordered Breathing

?Aggregate evidence quality: Grade C, before-and-after observational studies and systematic reviews ?Benefit: Identify children who require further man-agement of SDB; improve outcomes

?Harm: None

?Cost: Time spent in counseling

?Benefits-harm assessment: Preponderance of benefit over harm

?Value judgments: Perception of inadequate counsel-ing by physicians and underappreciation that SDB

may persist or recur despite tonsillectomy

?Role of patient preferences: Limited

?Intentional vagueness: None

?Exclusions: None

?Policy level: Recommendation

STATEMENT 7. INTRAOPERATIVE STEROIDS: Clini-cians should administer a single, intraoperative dose of intravenous dexamethasone to children undergoing tonsil-lectomy. Strong recommendation based on randomized controlled trials and systematic reviews of randomized con-trolled trials with a preponderance of benefit over harm.Supporting Text

One of the most important morbidities associated with pediatric tonsillectomy is postoperative nausea and vomiting (PONV). PONV occurs independent of dissection technique138and in more than 70% of children who do not receive prophylactic anti-emetics.139-141 Because of its very nature to cause discomfort and pain, PONV is acutely distressing to the patient. PONV often necessitates overnight hospital admission to provide intravenous hydration and analgesic administration and is associated with decreased patient satisfaction and increased use of resources.142-144 For several decades, evidence has accumulated that the administration of a single intraoperative dose of dexametha-sone in children undergoing tonsillectomy results in decreased PONV.145-154 A systematic review from the Cochrane Collabo-ration showed that children receiving dexamethasone were less likely to vomit in the first 24 hours than children receiv-ing placebo (relative risk, 0.54; 95% CI, 0.42-0.69) and more likely to advance to a soft or solid diet on posttonsillec-tomy day 1 (relative risk, 1.69; 95% CI, 1.02-2.79).153On average, about 4 children would need to receive intravenous dexamethasone to result in 1 fewer patient experiencing post-tonsillectomy emesis (number needed to treat = 4).153,154 The mechanism of efficacy of dexamethasone is unknown but may be related to its anti-inflammatory properties that reduce pain and swelling.155-157 Most published studies used a dexamethasone dose of 0.5 mg/kg150; however, lower doses may be equally effective.158,159 In one systematic review of ran-domized controlled trials, for example, doses ranged from 0.15 to 1.00 mg/kg, with a maximum dose range of 8 to 25 mg.153 Additional comorbidities after tonsillectomy include pain, poor oral intake, and changes in voice character. In addition to having a beneficial effect on PONV, dexamethasone also decreases throat pain after tonsillectomy and time to resump-tion of oral intake,160-162 which may be of particular benefit when electrosurgery is used to remove the tonsils.

There is little evidence that administration of a single dose of dexamethasone in nondiabetic patients results in harmful effects. No adverse events were reported in any of the trials included in the Cochrane review, nor were any reports found in the literature of complications from using a single intrave-nous dose of corticosteroid during pediatric tonsillectomy.153 One trial published after this review found increased postop-erative hemorrhage in children who were randomized to receive 0.5 mg/kg of dexamethasone.150 However, this was a secondary outcome that was not adjusted for other risk factors and lost significance when primary hemorrhage cases, which are largely related to surgical technique, were excluded from the analysis.163Increased hemorrhage with dexamethasone has not occurred in any other published trials, and the signifi-cance of this single report has been challenged.163 Evidence Profile for Statement 7:

Intraoperative Steroids

?Aggregate evidence quality: Grade A, randomized controlled trials and multiple systematic reviews, for

preventing PONV; Grade A, randomized controlled

T able 7.T onsillectomy and Sleep-Disordered Breathing (SDB) Caregiver Counseling Summary

1. Hypertrophic tonsils may contribute to SDB in children.

2. SDB often is multifactorial.

3. Obesity plays a key role in SDB in some children.

4. PSG is considered the best test for diagnosing and measuring

outcomes in children, but it is not necessary in all cases and access may be limited by availability of sleep laboratories and willingness of insurers and third-party payers to cover the cost of testing.

5. T onsillectomy is effective for control of SDB in 60%-70% of

children with significant tonsillar hypertrophy.

6. T onsillectomy produces resolution of SDB in only 10%-25% of

obese children.

7. Caregivers need to be counseled that tonsillectomy is not

curative in all cases of SDB in children, especially in children with obesity.

Baugh et al S17

trials and 1 systematic review, for decreased pain and

shorter times to oral intake

?Benefit: Decreased incidence of PONV up to 24 hours posttonsillectomy, decreased times to first oral

intake, and decreased pain as measured by lower

pain scores and longer latency times to analgesic

administration

?Harm: No adverse events in all randomized con-trolled trials except one, which reported increased

hemorrhage as a secondary outcome unadjusted for

other risk factors

?Cost: Direct cost of medication and indirect costs of drug administration

?Benefits-harm assessment: Preponderance of benefit over harm

?Value judgments: Decreased PONV and postopera-tive pain likely to result in increased patient

satisfaction and decreased incidence of overnight

hospital admission, associated with lower total health

care costs compared with direct and indirect costs of

drug administration

?Role of patient preferences: None

?Intentional vagueness: None

?Exclusions: Patients with endocrine disorders who are already receiving exogenous steroids or in whom

steroid administration may interfere with normal

glucose-insulin regulation (eg, diabetics)

?Policy level: Strong recommendation

STATEMENT 8. PERIOPERATIVE ANTIBIOTICS: Cli-nicians should not routinely administer or prescribe perioperative antibiotics to children undergoing tonsillec-tomy. Strong recommendation against administering or prescribing based on randomized controlled trials and sys-tematic reviews with a preponderance of benefit over harm. Supporting Text

The purpose of this statement is to address the issue of how antimicrobial therapy affects recovery after tonsillectomy and whether routine use is justified. Early randomized controlled trials of antibiotic therapy have largely shaped the delivery of care by otolaryngologists, suggesting improved recovery after tonsillectomy when antibiotics were prescribed.164,165Up to 79% of polled otolaryngologists in the United States use anti-biotics in patients undergoing tonsillectomy to reduce postoperative morbidity, presumably through a reduction in bacteremia or through the anti-inflammatory properties of some antibiotics.166

The accumulated body of evidence, however, brings into question these early suggestions of benefit, because of method-ological limitations in older trials and because of newer trials, which in aggregate do not support any benefit for routine anti-microbial therapy in the perioperative period. In an outpatient setting, the term perioperative in considered to mean the 24 hours prior to and following the surgical procedure. Patients excluded from these studies were those requiring preoperative prophylactic antibiotics because of heart murmurs, implants, or other recognized reasons. Other exclusions included unilateral tonsillectomy, tonsillar biopsy, known tonsillar carcinoma, or tonsillectomy in conjunction with palatal surgery.

A Cochrane review of 10 randomized controlled trials found “no evidence to support a consistent, clinically impor-tant impact of antibiotics in reducing the main morbid outcomes after tonsillectomy.”167 In the pooled analyses, anti-biotics had no impact on rates of secondary hemorrhage (of any severity; 7 trials) or on significant secondary hemorrhage (requiring readmission, blood transfusion, or return to the operating room; 3 trials). An additional pooled analysis (2 trials) showed reduced incidence of fever greater than 99.9°F with antibiotics, but 2 other trials (not suitable for pooled anal-ysis) showed no benefit.

The impact of antibiotics on pain, diet, and activity was not suitable for meta-analysis in the Cochrane review, but indi-vidual trials primarily showed no benefits. Antibiotics had no impact on pain in 5 of 7 trials, no impact (or an uncertain impact) on analgesic use in 5 of 6 trials, no impact on time to normal activity in 4 of 6 trials, and no impact on time to normal diet in 4 of 7 trials. When benefits were observed, they were generally small (1- to 2-day differences in return to normal diet) and were potentially explainable by bias in study design or outcome assessment. The authors of the Cochrane review concluded that antibiotics should be used “with cau-tion” after tonsillectomy, a sentiment reflected in subsequent reviews and commentaries.168-170

Conclusions of no beneficial effects for antibiotics in the Cochrane review do not appear to be related to insufficient evidence or flaws in study design. The evidence base of 10 randomized controlled trials between 1986 and 2008 with 1035 participants is sufficient to draw conclusions, with the 3 trials published in 2000 or later showing no benefits for any outcomes. Although the trials had significant design flaws (90% inadequate allocation concealment, 80% not suitable for intent-to-treat analysis, 50% inadequate double blinding), these limitations would produce bias favoring antibiotics, which was not observed in the overall results. The trials were also heterogeneous, but this was unlikely to affect conclusions because results from individual trials broadly conformed to one another and to meta-analysis, when performed.

Any real or theoretical benefit of antibiotics on recovery after tonsillectomy must be balanced against the known risks, harms, and adverse events of therapy.171 Aside from the direct costs of acquiring the drug, adverse events include rash, allergy, and gastrointestinal upset or diarrhea. Adverse events from antibiotics account for about 20% of all drug-related emergency department visits in the United States, most of which are attributable to allergic reactions.171 Allergy to b-lactam antibiotics is cited as 2% per course, and anaphylaxis is estimated to occur in 0.01% to 0.05% of all penicillin courses.167

Antimicrobial use is also a well-known promoter of bacte-rial resistance, which is of particular concern in young children, who often require antimicrobials for otitis media, bacterial

S18 Otolaryngology–Head and Neck Surgery 144(1S)

sinusitis, and other infections. Last, an important consideration not discussed in the literature is the burden of trying to get the patient to swallow another liquid he or she struggles to take postoperative fluids. This creates an additional load on caregiv-ers in the early postoperative period and may explain the high overall dropout rate observed in many studies of antibiotics and tonsillectomy.

The routine use of antibiotics after tonsillectomy in the face of increasing bacterial resistance, risk of allergic reactions, or other side effects should be weighed against the possible reduc-tion in postoperative fever, which is the only outcome for which a significant benefit has been observed. The possibility of bias in explaining the sole significant outcome must also be considered. The absence of good evidence for the effectiveness of antibiotics to provide clinically relevant benefit confirms that there is insufficient evidence to support their routine use as a method to reduce morbidity after pediatric tonsillectomy. Evidence Profile for Statement 8:

Perioperative Antibiotics

?Aggregate evidence quality: Grade A, randomized controlled trials and systematic reviews, showing no

benefit in using perioperative antibiotics to reduce

posttonsillectomy morbidity

?Benefit: Avoidance of adverse events related to anti-microbial therapy, including rash, allergy, gastrointestinal

upset, and induced bacterial resistance

?Harm: None

?Cost: None

?Benefits-harm assessment: Preponderance of benefit over harm

?Value judgments: Although the panel recognizes that antimicrobial therapy is often used in perioperative

management, this practice is suboptimal given the

lack of demonstrable benefits in randomized con-

trolled trials plus the well-documented potential

adverse events and cost of therapy

?Role of patient preferences: None

?Intentional vagueness: The panel advises against routine antimicrobial therapy, recognizing that there

may be individual circumstances in which use of

antimicrobials for a given patient is deemed appro-

priate by the clinician

?Exclusions: Patients with cardiac conditions requiring perioperative antibiotics for prophylaxis against bac-

terial endocarditis or implants; patients undergoing

tonsillectomy with concurrent peritonsillar abscess ?Policy level: Strong recommendation against STATEMENT 9. POSTOPERATIVE PAIN CONTROL: The clinician should advocate for pain management after tonsillectomy and educate caregivers about the impor-tance of managing and reassessing pain. Recommendation based on randomized controlled trials with limitations and observational studies with a preponderance of benefit over harm.Supporting Text

The purpose of this statement is to prevent pain and decrease morbidity following tonsillectomy, based on a perception by the panel that pain control may be underemphasized or inad-equately discussed with the child’s caregiver (T able 8). The main cause of morbidity after tonsillectomy is oropharyngeal pain, which may result in decreased oral intake, dysphagia, dehydration, and weight loss. As discussed previously, a single dose of intravenous dexamethasone reduces PONV and pain after tonsillectomy, but perioperative antibiotics are inef-fective and not recommended. This section deals with additional measures for postoperative pain control, seeking to educate and empower caregivers and patients in the process.

Clinicians should advocate for pain management by estab-lishing strategies to control pain after tonsillectomy. The panel avoided a recommendation to prescribe specific drugs, since pain can often be managed with over-the-counter analgesics and hydration. Educating caregivers about the need to manage and reassess pain is also part of the action statement, because caregivers have the most frequent contact with the child and are often best suited to monitor the child frequently after sur-gery. Clinicians are encouraged to advocate and educate prior to surgery and to reinforce the education prior to discharge on the day of tonsillectomy. Documentation should appear in the medical record describing how this was accomplished (eg, verbal discussion, written handout, educational brochure).

Education and perioperative strategies.Preoperative educa-tion programs targeting the caregivers are well established, but a focus on the child’s understanding of the procedure is relatively new. Recent advances in the understanding of chil-dren’s preprocedure education studies has identified T able 8. Posttonsillectomy Pain Management Education for Caregivers

1. Throat pain is greatest the first few days following surgery and

may last up to 2 wk.

2. Encourage your child to communicate with you if he or she

experiences significant throat pain, since pain may not always be expressed and therefore not recognized promptly.

3. Discuss strategies for pain control with your health care

provider before and after surgery; realize that antibiotics after surgery do not reduce pain and should not be given routinely for this purpose.

4. Make sure your child drinks plenty of fluids after surgery. Staying

well hydrated is associated with less pain.

5. Ibuprofen can be used safely for pain control after surgery.

6. Pain medicine should be given as directed by your health care

provider. Especially for the first few days following surgery, it

should be given often.

7. Many clinicians recommend not waiting until your child

complains of pain. Instead, the pain medication should be given on a regular schedule.

8. Expect your child to complain more about pain in the

mornings—this is normal.

9. Rectal administration may be given if your child refuses to take

pain medication orally. Call your health care provider if you are unable to adequately control your child’s pain.

Baugh et al S19

preoperative pain education as valuable for children prior to tonsillectomy.172,173 Although concerns have been expressed about the possibility of pain education increasing children’s anticipatory anxiety and adversely influencing their postop-erative pain experience,174recent experience has suggested such concerns may be unfounded.175 The preoperative intro-duction and teaching of a numeric pain intensity scale is useful for children to communicate their pain experience; however, it does not decrease anxiety or pain intensity, improve the qual-ity of sleep or pain, or increase oral intake.175

Intraoperatively, local anesthesia injections in the tonsillar fossae have been used to reduce morbidity. A Cochrane review assessed the effects of preoperative and postoperative local anesthesia for pain reduction following tonsillectomy.176 Ran-domized controlled trials of adults and children that were included in the review found no evidence that the use of peri-operative local anesthetic in patients undergoing tonsillectomy improves postoperative pain control. The results suggest that local anesthetics should not be used as they have not been proven to be effective for postoperative pain control.

Despite the efforts of surgeons intraoperatively to decrease postoperative pain, the first few days following tonsillectomy are problematic. Oral intake improves over time but is highly variable between children.172,177Investigations into the oral fluid intake at home following tonsillectomy in the United States is limited but strongly suggests hydration is inadequate for most children following tonsillectomy.177-180 This is impor-tant because inadequate hydration has been reported to be associated with increased reports of pain following tonsillec-tomy.181Most reported studies do not control or report the fluid intake of their subjects. Food intake is similarly reduced and often results in weight loss. It has not been the focus of extensive research, but dietary restrictions following surgery do not appear to be important.182,183

A significant contributing factor to poorly controlled postop-erative pain may be noncompliant caregivers. American data177,184-186 have mirrored the European experience regarding the inadequacy of caregiver compliance with the administration of analgesics following tonsillectomy.184,187-189Fortier and col-leagues185 recently showed that up to 24% of children received either no pain medication or a single dose on the first postopera-tive day, despite caregivers indicating that their children were in severe pain. By day 3 following surgery, despite 67% of the chil-dren experiencing severe pain, 41% received no pain medication or a single dose throughout the day. Other reported prospective, controlled experimental evidence has not found that compliance is a problem, although that was not the focus of the study.190 Topical agents have been used in an effort to reduce post-operative pain. A variety of oral rinses, mouthwashes, and sprays have been used. A recent Cochrane review analyzed 6 trials including nearly 400 children191; however, the risk of bias was high in most studies, the reporting quality poor, and the data inadequate to permit comprehensive and reliable con-clusions to be made.

Oral analgesics after tonsillectomy.Although widely used, acet-aminophen with codeine does not provide superior control of pain compared with acetaminophen only following tonsillectomy either at rest or with swallowing.192,193 The level of useful pain relief was similar to that reported in adults with moderate to severe postoperative pain.194 Some of codeine’s lack of efficacy may be due to the substantial genetic variation that exists in the activity of the cytochrome P450 enzyme CYP2D6, which is responsible for the metabolism of codeine into its active metabo-lite morphine. The presence of this polymorphism may render codeine ineffective,195,196 and ultrarapid metabolism of codeine may put some children at risk with the use of codeine.197 Postop-erative nausea, vomiting, and constipation from acetaminophen with codeine use has led some to use just acetaminophen; how-ever, acetaminophen alone may not provide adequate analgesia.198 Rectal administration of medication was better tolerated than oral administration of acetaminophen and codeine.199

The use of nonsteroidal anti-inflammatory drugs (NSAIDs) after tonsillectomy has been controversial because of adverse effects on platelet function that may prolong bleeding time and other parameters.200,201 A review from the Cochrane Col-laboration202 with nearly 1000 children from 13 randomized controlled trials found that NSAIDs did not significantly alter postoperative bleeding compared with placebo or other anal-gesics (odds ratio, 1.46; 95% CI, 0.49-4.40). In a subgroup analysis of 7 trials involving 567 children, the odds ratio for bleeding requiring reoperation was 0.91 (CI, 0.22-3.71) when ketorolac was excluded, suggesting no significant impact. These data suggest that NSAIDs, ketorolac excluded, can be safely used for the postoperative treatment of pain following tonsillectomy. Posttonsillectomy hemorrhage rates with ketor-olac range from 4.4% to 18%, and therefore ketorolac use should be avoided.203,204

Administration of pain medication according to a fixed schedule is widely embraced but has not been proven to be superior to dosing the medication as needed (PRN).205 Four randomized clinical trials evaluating the effectiveness of around-the-clock dosing of analgesics in children following tonsillectomy have been completed.190,192,206,207 Pain regimens using acetaminophen,206acetaminophen and codeine,192and rofecoxib and hydrocodone207 are equivalent, and despite the medications, children still experienced moderate levels of pain. The most recent study compared acetaminophen with hydrocodone PRN dosing around the clock. Time-dependent dosing was more effective than PRN dosing, and again, mod-erate pain in the study subjects was demonstrated.190 Discomfort after tonsillectomy is greater in the mornings than the evenings, independent of the dosing schedule, even when around-the-clock dosing was employed.172,190 A variety of explanations has been offered for the increase in morning dis-comfort: decreased nocturnal caregiver analgesic administration or home environment distractions during the day,187,208 muscle spasm, increased edema secondary to positioning, and poor sleep quality.190 An equally likely plausible explanation is that the children become relatively dehydrated overnight.177,181 Sleep disturbances may occur,172,209-211and awakenings during the night may reflect inadequate control of postoperative pain and lessen as pain decreases.172Individual child factors have also been implicated as predictors of sleep disturbances and other maladaptive postoperative behavioral changes.212