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Guideline Summary NGC-8208

Guideline Title Clinical practice guideline: tonsillectomy in children. Bibliographic Source(s) Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM, American Academy of Otolaryngology-Head and NeckSurgeryFoundation.Clinicalpracticeguideline:tonsillectomyinchildren.OtolaryngolHeadNeckSurg2011 Jan;144(1 Suppl):S1-30. [229 references] PubMed Guideline Status This is the current release of the guideline.

Scope
Disease/Condition(s) Recurrent throat infections and/or sleep-disordered breathing for which tonsillectomy is indicated Guideline Category Counseling Evaluation Management Treatment Clinical Specialty Anesthesiology Family Practice Infectious Diseases Internal Medicine Otolaryngology Pediatrics Sleep Medicine Surgery Intended Users Advanced Practice Nurses Hospitals Physician Assistants Physicians Guideline Objective(s) l Toprovideclinicianswithevidence-based guidance in identifying children who are the best candidates for tonsillectomy
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Tooptimizetheperioperativemanagementofchildrenundergoingtonsillectomy Toemphasizetheneedforevaluationandinterventioninspecialpopulations Toimprovecounselingandeducationoffamiliesofchildrenwhoareconsideringtonsillectomyfortheirchild Tohighlightthemanagementoptionsforpatientswithmodifyingfactors Toreduceinappropriateorunnecessaryvariationsincare

Target Population Children 1 to 18 years old under consideration for tonsillectomy

Note: The guideline does not apply to populations of children excluded from most tonsillectomy research studies, including those with diabetes mellitus, cardiopulmonary disease, craniofacial disorders, congenital anomalies of the head and neck region, sickle cell disease, and other coagulopathies or immunodeficiency disorders.

Interventions and Practices Considered Counseling/Evaluation

Target Population Children 1 to 18 years old under consideration for tonsillectomy

Note: The guideline does not apply to populations of children excluded from most tonsillectomy research studies, including those with diabetes mellitus, cardiopulmonary disease, craniofacial disorders, congenital anomalies of the head and neck region, sickle cell disease, and other coagulopathies or immunodeficiency disorders.

Interventions and Practices Considered Counseling/Evaluation 1.Educatingcaregiversabouttonsillectomyasameanstoimprovehealthinchildrenwithabnormal polysomnography who also have tonsil hypertrophy and sleep-disordered breathing (SDB) 2.EducatingcaregiversregardingpostoperativeSDB 3."Watchfulwaiting"forrecurrentthroatinfectionbasedonnumberofepisodesofinfection 4.Assessingchildformodifyingfactorsfavoringtonsillectomy 5.DocumentationofcomorbidconditionsinchildrenwithSDBandtonsilhypertrophy Treatment/Management 1.Tonsillectomyforchildrenwithrecurrentinfectionthatmeetscriteriaforfrequency,severity,treatment,and documentation of illness 2.Useofsingleintraoperativedoseofdexamethasone 3.Useofperioperativeantibiotics(recommendationagainstroutineuse) 4.Postoperativepainmanagement(providinginformation,prescribing,educatingcaregiversaboutpainrelief) 5.Documentationofrateofpost-tonsillectomy hemorrhage Major Outcomes Considered l Frequencyandseverityofthroatinfection
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Qualityoflife Functionalandbehavioraloutcomesinchildrenwithsleep-disordered breathing Morbidityoftonsillectomy Incidenceofpostoperativenauseaandvomiting Painrelief,recoveryrate,andrateofcomplicationsfromdehydrationorinadequatefoodintake Ratesofprimaryandsecondaryhemorrhagefollowingtonsillectomy

Methodology
Methods Used to Collect/Select the Evidence Searches of Electronic Databases Searches of Unpublished Data Description of Methods Used to Collect/Select the Evidence 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 (see Table 1 in the original guideline document). 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.Publishedandunpublishedconsensus- 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 guidelines met quality criteria of having been produced under the auspices of a medical association or organization and having an explicit, a priori, method for ranking evidence and linking evidence to recommendations. 2.Systematicreviewslessthan15yearsandmeta-analyses with a systematic review in English met 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 EvidenceCancer. Reviews 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.RandomizedcontrolledtrialspublishedinEnglishwithnoagerestrictionswereidentifiedusinganadaptationof the Cochrane Highly Sensitive Search Strategy. Published or unpublished completed trials with a definite or possible randomized controlled 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), surgical indications (24), antibiotics (16), outcomes assessment (15), surgical complications (2), perioperative 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. Number of Source Documents l 17guidelines
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36systematicreviews 705studies

Methods Used to Assess the Quality and Strength of the Evidence Expert Consensus (Committee)

identified in developing the guideline through April 11, 2010. Number of Source Documents l 17guidelines
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36systematicreviews 705studies

Methods Used to Assess the Quality and Strength of the Evidence Expert Consensus (Committee) Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Evidence Quality for Grades of Evidence Grade A: Well-designed randomized controlled trials or diagnostic studies performed on a population similar to the guideline's target population Grade B: Randomized controlled trials or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies Grade C: Observational studies (case control and cohort design) Grade D: Case reports, reasoning from first principles (bench research or animal studies) Grade X: Exceptional situations in which validating studies cannot be performed and there is a clear preponderance of benefit over harm Methods Used to Analyze the Evidence Review of Published Meta-Analyses Systematic Review Description of the Methods Used to Analyze the Evidence The evidence-based approach to guideline 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 statements are listed in "Ratings Scheme for the Strength of the Evidence" and "Rating Scheme for the Strength of the Recommendations" fields. Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations 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. The guideline panel was chosen to represent fields of sleep medicine, advanced practice nursing, anesthesiology, infectious disease, family medicine, otolaryngologyhead and neck surgery, pediatrics, and consumers. Several group members had prior experience in developing clinical practice guidelines. 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 feedback on each guideline draft to ensure accuracy of content and consistency with standardized criteria for reporting clinical practice guidelines. The Guideline Implementability Appraisal and Extractor tool was used to appraise adherence of the draft guideline to methodological standards, to improve clarity of recommendations, and to predict potential obstacles to implementation. Guideline panel members received summary appraisals in May 2010 and modified an advanced draft of the guideline. Rating Scheme for the Strength of the Recommendations Guideline Definitions for Evidence-Based Statements 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)*. 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. Implication: 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)*. In some clearly identified circumstances, recommendations may be made on the basis of lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. Implication: Clinicians should also 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)* or that well-done studies (Grade A, B, or C)* show little clear advantage to one approach versus another. Implication: 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)* and an unclear balance between benefits and harms. Implication: 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.
*Refer to "Rating Scheme for the Strength of the Evidence" field for the definitions of evidence grades.

Cost Analysis

(Grade A, B, or C)* show little clear advantage to one approach versus another. Implication: 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)* and an unclear balance between benefits and harms. Implication: 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.
*Refer to "Rating Scheme for the Strength of the Evidence" field for the definitions of evidence grades.

Cost Analysis The guideline developers reviewed published cost analyses. Method of Guideline Validation Comparison with Guidelines from Other Groups External Peer Review Internal Peer Review Description of Method of Guideline Validation 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 publication. The recommendations were also compared with guidelines for tonsillectomy from the Italian National Program Guidelines and the Scottish Intercollegiate Guidelines Network (see Table 9 in the original guideline document for a detailed comparison).

Recommendations
Major Recommendations The evidence grades (A-D, X) and evidence-based statements (Strong Recommendation, Recommendation, and Option) are defined at the end of the "Major Recommendations" field. Statement 1. Watchful Waiting for Recurrent Throat Infection Clinicians should recommend 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. Recommendation based on randomized controlled trials with limitations and observational studies with a preponderance of benefit over harm. Evidence Profile Aggregateevidencequality:GradeB,randomizedcontrolledtrialswithminorlimitationsthatfailtoshowclinically important advantages of surgery over observation alone (as stated in Statement 1), and Grade C, observational studies showing improvement with watchful waiting
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Benefit:Avoidunnecessarysurgerywithpotentialcomplicationsofvomiting,hemorrhage,pain,infection,or anesthesia problems

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Harm:Waitingmayresultindelayedtreatmentinpatientswhohaveunusuallyfrequentandsevererecurrent throat infections

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Cost:Potentialdirectcostofmanagingfuturethroatinfections Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:Panelconsensusthattonsillectomyforrecurrentthroatinfectionshouldbelimitedto circumstances 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 Roleofpatientpreferences:Limitedtospecificunusualcircumstancessuchascomplicationsoftonsillitisor comorbidities
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Intentionalvagueness:None

Exclusions:Patientswithperitonsillarabscess,personalorfamilyhistoryofrheumaticheartdisease,Lemierre syndrome, or severe infections requiring hospitalization

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Policylevel:Recommendation

Statement 2. Recurrent Throat Infection with Documentation Clinicians may recommend tonsillectomy for recurrent throat infection 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 themedicalrecordforeachepisodeofsorethroatandoneormoreofthefollowing:temperature>38.3C,cervical adenopathy, tonsillar exudate, or positive test for Group A -hemolytic streptococcus (GABHS). Option based on systematic reviews and randomized controlled trials with minor limitations, with a balance between benefit and harm. Evidence Profile Aggregateevidencequality:GradeB,well-designed randomized controlled trials with minor limitations; some Grade C observational studies
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Benefit:Modestreductioninthefrequencyandseverityofrecurrentthroatinfectionforupto2yearsafter surgery; modest reduction in frequency of group A streptococcal infection for up to 2 years after surgery; improved disease-specific quality of life (QoL)
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Harm:Riskandmorbidityoftonsillectomyinpatientsappropriatelyselectedfortheprocedure,including,butnot limited to, persistence of throat infection, pain, and missed activity after surgery, hemorrhage, dehydration, injury, and anesthetic complications
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Cost:Directcostoftonsillectomydirectnonsurgicalcosts(antibiotics,clinicianvisit)andindirectcosts(caregiver

Evidence Profile Aggregateevidencequality:GradeB,well-designed randomized controlled trials with minor limitations; some Grade C observational studies
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Benefit:Modestreductioninthefrequencyandseverityofrecurrentthroatinfectionforupto2yearsafter surgery; modest reduction in frequency of group A streptococcal infection for up to 2 years after surgery; improved disease-specific quality of life (QoL)
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Harm:Riskandmorbidityoftonsillectomyinpatientsappropriatelyselectedfortheprocedure,including,butnot limited to, persistence of throat infection, pain, and missed activity after surgery, hemorrhage, dehydration, injury, and anesthetic complications
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Cost:Directcostoftonsillectomydirectnonsurgicalcosts(antibiotics,clinicianvisit)andindirectcosts(caregiver time, time missed from school) associated with recurrent infection
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Benefits-harm assessment: Balance between benefit and harm

Valuejudgments:Importanceofbalancingthemodest,short-term benefits of tonsillectomy in carefully 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 Roleofpatientpreferences:Largeroleforshareddecisionmakinginseverelyaffectedpatients,givenfavorable natural history of recurrent throat infections and modest improvement associated with surgery; limited role in patients who do not meet strict indications for surgery
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Intentionalvagueness:None Exclusions:None Policylevel:Option

Statement 3. Tonsillectomy for Recurrent 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 tonsillectomy, which may include but are not limited to multiple antibiotic allergy/intolerance, PFAPA (periodic fever, aphthous stomatitis, pharyngitis, and adenitis), or history of peritonsillar abscess. Recommendation based on randomized controlled trials and observational studies with a preponderance of benefit over harm. Evidence Profile Aggregateevidencequality:GradeB,randomizedcontrolledtrialswithlimitations,forPFAPAGradeC, observational studies for all other factors
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Benefit:Identifyingfactorsthatmightotherwisehavebeenoverlooked,whichmayinfluencethedecisionto perform tonsillectomy and ultimately improve patient outcomes

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Harm:None Cost:None Benefits-harm assessment: Preponderance of benefit over harm Valuejudgments:None Roleofpatientpreferences:Shouldbeincluded Intentionalvagueness:None Exclusions:None Policylevel:Recommendation

Statement 4. Tonsillectomy for Sleep-disordered Breathing (SDB) Clinicians should ask caregivers of children with SDB 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. Evidence Profile
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Aggregateevidencequality:GradeC,before-and after observational studies

Benefit:ToimprovedecisionmakinginchildrenwithSDBbyidentifyingcomorbidconditionsassociatedwithSDB, which might otherwise have been overlooked, and may improve after tonsillectomy
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Harm:None Cost:None Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:Perceptionthatpotentiallyimportantcomorbidconditionsmaybeoverlookedornotincludedin 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 controlled trials supporting a recommendation for or against tonsillectomy
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Roleofpatientpreferences:Largeroleforcaregivereducationandshareddecisionmaking Intentionalvagueness:None Exclusions:None Policylevel:Recommendation

Statement 5. Tonsillectomy and Polysomnography (PSG) Clinicians should counsel caregivers about tonsillectomy as a means to improve health in children with abnormal PSG who also have tonsil hypertrophy and SDB. Recommendation based on observational before-and-after studies with a preponderance of benefit over harm. Evidence Profile: Tonsillectomy and PSG Aggregateevidencequality:GradeC,observational,before-and-after studies and meta-analysis of observational studies showing substantial reduction in the prevalence of SDB and abnormal PSG after tonsillectomy
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Policylevel:Recommendation

Statement 5. Tonsillectomy and Polysomnography (PSG) Clinicians should counsel caregivers about tonsillectomy as a means to improve health in children with abnormal PSG who also have tonsil hypertrophy and SDB. Recommendation based on observational before-and-after studies with a preponderance of benefit over harm. Evidence Profile: Tonsillectomy and PSG Aggregateevidencequality:GradeC,observational,before-and-after studies and meta-analysis of observational studies showing substantial reduction in the prevalence of SDB and abnormal PSG after tonsillectomy
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Benefit:ImprovedcaregiverawarenessofhowtonsillectomymaybenefittheirchildwhenPSGisabnormal, including improved sleep, better nighttime and daytime functioning, improved functional health status, and prevention or improvement of comorbid conditions, including growth retardation, poor school performance, enuresis, and behavioral problems
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Harm:Potentialanxietytocaregiversfromcounseling Cost:None Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:PanelconsensusthatobjectivelydocumentedSDBwithPSGmaywarrantintervention,evenif not associated with comorbid conditions; recognition that abnormal PSG results encompass a broad range of values, with lack of evidence to support 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
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Roleofpatientpreferences:Moderatedifferentcaregiversmayseekdifferentlevelsofinformationanddetail

Intentionalvagueness:Thepanelusesthetermabnormal PSG recognizing there is no consensus among clinicians, institutions, or disciplines regarding 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
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Exclusions:Noneforcounseling Policylevel:Recommendation

Statement 6. Outcome Assessment for SDB Clinicians should counsel caregivers and explain that SDB may persist or recur after tonsillectomy and may require further management. Recommendation based on observational studies, case-control and cohort design, with a preponderance of benefit over harm. Evidence Profile
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Aggregateevidencequality:GradeC,before-and-after observational studies and systematic reviews Benefit:IdentifychildrenwhorequirefurthermanagementofSDBimproveoutcomes Harm:None Cost:Timespentincounseling Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:PerceptionofinadequatecounselingbyphysiciansandunderappreciationthatSDBmaypersist or recur despite tonsillectomy

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Roleofpatientpreferences:Limited Intentionalvagueness:None Exclusions:None Policylevel:Recommendation

Statement 7. Intraoperative Steroids Clinicians should administer a single, intraoperative dose of intravenous dexamethasone to children undergoing tonsillectomy. Strong recommendation based on randomized controlled trials and systematic reviews of randomized controlled trials with a preponderance of benefit over harm. Evidence Profile Aggregateevidencequality:GradeA,randomizedcontrolledtrialsandmultiplesystematicreviews,forpreventing postoperative nausea and vomiting (PONV); Grade A, randomized controlled trials and 1 systematic review, for decreased pain and shorter times to oral intake
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Benefit:DecreasedincidenceofPONVupto24hourspost-tonsillectomy, decreased times to first oral intake, and decreased pain as measured by lower pain scores and longer latency times to analgesic administration
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Harm:Noadverseeventsinallrandomizedcontrolledtrialsexceptone,whichreportedincreasedhemorrhageasa secondary outcome unadjusted for other risk factors

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Cost:Directcostofmedicationandindirectcostsofdrugadministration Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:DecreasedPONVandpostoperativepainlikelytoresultinincreasedpatientsatisfactionand decreased incidence of overnight hospital admission, associated with lower total health care costs compared with direct and indirect costs of drug administration
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Roleofpatientpreferences:None Intentionalvagueness:None

Exclusions:Patientswithendocrinedisorderswhoarealreadyreceivingexogenoussteroidsorinwhomsteroid administration may interfere with normal glucose-insulin regulation (e.g., diabetics)
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Policylevel:Strongrecommendation

Statement 8. Perioperative Antibiotics

Valuejudgments:DecreasedPONVandpostoperativepainlikelytoresultinincreasedpatientsatisfactionand decreased incidence of overnight hospital admission, associated with lower total health care costs compared with direct and indirect costs of drug administration
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Roleofpatientpreferences:None Intentionalvagueness:None

Exclusions:Patientswithendocrinedisorderswhoarealreadyreceivingexogenoussteroidsorinwhomsteroid administration may interfere with normal glucose-insulin regulation (e.g., diabetics)
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Policylevel:Strongrecommendation

Statement 8. Perioperative Antibiotics Clinicians should not routinely administer or prescribe perioperative antibiotics to children undergoing tonsillectomy. Strong recommendation against administering or prescribing based on randomized controlled trials and systematic reviews with a preponderance of benefit over harm. Evidence Profile Aggregateevidencequality:GradeA,randomizedcontrolledtrialsandsystematicreviews,showingnobenefitin using perioperative antibiotics to reduce post-tonsillectomy morbidity
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Benefit:Avoidanceofadverseeventsrelatedtoantimicrobialtherapy,includingrash,allergy,gastrointestinal upset, and induced bacterial resistance

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Harm:None Cost:None Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:Althoughthepanelrecognizesthatantimicrobialtherapyisoftenusedinperioperative management, this practice is suboptimal given the lack of demonstrable benefits in randomized controlled trials plus the well-documented potential adverse events and cost of therapy
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Roleofpatientpreferences:None

Intentionalvagueness:Thepaneladvisesagainstroutineantimicrobialtherapy,recognizingthattheremaybe individual circumstances in which use of antimicrobials for a given patient is deemed appropriate by the clinician Exclusions:Patientswithcardiacconditionsrequiringperioperativeantibioticsforprophylaxisagainstbacterial endocarditis or implants; patients undergoing tonsillectomy with concurrent peritonsillar abscess
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Policylevel:Strongrecommendationagainst

Statement 9. Postoperative Pain Control The clinician should advocate for pain management after tonsillectomy and educate caregivers about the importance of managing and reassessing pain. Recommendation based on randomized controlled trials with limitations and observational studies with a preponderance of benefit over harm. Evidence Profile Aggregateevidencequality:GradeB,randomizedcontrolledtrialscomparinganalgesicsaftertonsillectomy,and Grade C, observational studies suggesting inadequate pain control and hydration after tonsillectomy
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Benefit:Painrelief,improvedandfasterrecoveryavoidanceofcomplicationsfromdehydration,inadequatefood intake
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Harm:Adverseeffectsofspecificanalgesicpreparations Cost:Timespentbyclinicianadvocatingdirectcostofmedicationsused Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:Perceptionbythepanelthatpaincontrolisoftenunderemphasizedandinadequatelydiscussed after tonsillectomy; importance of engaging the caregiver and providing education about pain management and reassessment Roleofpatientpreferences:Limitedregardingadvocacysubstantialroleinchoiceofanalgesicandmethodof reassessment
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Intentionalvagueness:None Exclusions:None Policylevel:Recommendation

Statement 10. Post-tonsillectomy Hemorrhage Clinicians who perform tonsillectomy should determine their rate of primary and secondary post-tonsillectomy hemorrhage at least annually. Recommendation based on observational studies with a preponderance of benefit over harm. Evidence Profile Aggregateevidencequality:GradeC,observationalstudiesandlarge-scale audit, showing variability in postoperative hemorrhage rates and some association with surgical technique; Grade C, observational studies, showing hemorrhage as a consistent sequela of tonsillectomy with heterogeneity among studies
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Benefit:Improvepreoperativecounselingfortonsillectomyencouragequalityimprovementefforts Harm:None Cost:Administrativeburden Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:Perceivedheterogeneityamongcliniciansregardingknowledgeoftheirownhemorrhagerates after tonsillectomy; potential for clinicians to reassess their process of care and improve quality
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Roleofpatientpreferences:Limited Intentionalvagueness:Specificsofhowtodeterminethehemorrhageratearelefttotheclinician Exclusions:None

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Harm:None Cost:Administrativeburden Benefits-harm assessment: Preponderance of benefit over harm

Valuejudgments:Perceivedheterogeneityamongcliniciansregardingknowledgeoftheirownhemorrhagerates after tonsillectomy; potential for clinicians to reassess their process of care and improve quality
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Roleofpatientpreferences:Limited Intentionalvagueness:Specificsofhowtodeterminethehemorrhageratearelefttotheclinician Exclusions:None Policylevel:Recommendation

Definitions: Guideline Definitions for Evidence-Based Statements 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). 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. Implication: 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). 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. Implication: 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) or that well-done studies (Grade A, B, or C) show little clear advantage to one approach versus another. Implication: 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) and an unclear balance between benefits and harms. Implication: 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. Evidence Quality for Grades of Evidence Grade A: Well-designed randomized controlled trials or diagnostic studies performed on a population similar to the guideline's target population Grade B: Randomized controlled trials or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies Grade C: Observational studies (case-control and cohort design) Grade D: Case reports, reasoning from first principles (bench research or animal studies) Grade X: Exceptional situations in which validating studies cannot be performed and there is a clear preponderance of benefit over harm Clinical Algorithm(s) None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). The recommendations contained in the practice guideline are based on the best available published data through April 11, 2010. Where data were lacking, a combination of clinical experience and expert consensus was used.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits Tonsillectomy may improve quality of life (QoL) by reducing throat infections, health care provider visits, and the need for antibiotic therapy. Similarly, sleep disordered breathing (SDB) is associated with cognitive and behavioral impairment in children that usually improves after tonsillectomy along with QoL, sleep disturbance, and vocal quality. For benefits of specific interventions considered in the guideline, see the "Major Recommendations" field. Potential Harms l Tonsillectomyisasurgicalprocedurewithanassociatedmorbiditythatincludespossiblehospitalization,risksof anesthesia, prolonged throat pain, and financial costs. Acommoncomplicationoftonsillectomyisbleedingduringorafterthesurgery.Inpublishedreports,therateof 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%. Hemorrhage after tonsillectomy may result in readmission for observation or in further surgery to control bleeding.
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Operativecomplicationsoftonsillectomyincludetraumatotheteeth,larynx,pharyngealwall,orsoftpalate difficult intubation; laryngospasm; laryngeal edema; aspiration; 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.
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Postoperativecomplicationsoftonsillectomyincludenausea,vomiting,pain,dehydration,referredotalgia, postobstructive pulmonary edema, velopharyngeal insufficiency, and nasopharyngeal stenosis. Complications are more common in patients with craniofacial disorders, Down syndrome, cerebral palsy, major heart disease, or
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Acommoncomplicationoftonsillectomyisbleedingduringorafterthesurgery.Inpublishedreports,therateof 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%. Hemorrhage after tonsillectomy may result in readmission for observation or in further surgery to control bleeding.
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Operativecomplicationsoftonsillectomyincludetraumatotheteeth,larynx,pharyngealwall,orsoftpalate difficult intubation; laryngospasm; laryngeal edema; aspiration; 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.
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Postoperativecomplicationsoftonsillectomyincludenausea,vomiting,pain,dehydration,referredotalgia, postobstructive pulmonary edema, velopharyngeal insufficiency, and nasopharyngeal stenosis. Complications are more common in patients with craniofacial disorders, Down syndrome, cerebral palsy, major heart disease, or bleeding diatheses and in children younger than 3 years with polysomnography (PSG)proven obstructive sleep apnea (OSA).
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Aftertonsillectomy,about1.3%ofpatientsexperiencedelayeddischargeduringtheinitialhospitalstay,andup to 3.9% have secondary complications requiring readmission. The primary reasons for readmission or prolonged initial stay included pain, vomiting, fever, and tonsillar hemorrhage.
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Manyunusualandrarecomplicationsoftonsillectomyhavebeendescribed.Amongthesearereportsofvascular injury, subcutaneous emphysema, jugular vein thrombosis, atlantoaxial subluxation (Grisel syndrome), taste disorders (hypogeusia, ageusia, dysgeusia, and phantogeusia), and persistent neck pain (Eagle syndrome).
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Therearenocurrentestimatesoftonsillectomymortality,butaprospectiveauditreportedonlyonepostoperative death after 33,921 procedures in England and Northern Ireland. About one-third of deaths are attributable to bleeding, while the remainder are related to aspiration, cardiopulmonary failure, electrolyte imbalance, or anesthetic complications. Similarly, airway compromise is the major cause of death or major injury in malpractice claims after tonsillectomy.
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For additional harms associated with specific interventions considered in the guideline, see the "Major Recommendations" field.

Qualifying Statements
Qualifying Statements l Thisclinicalpracticeguidelineisnotintendedasasolesourceofguidanceinmanagingchildrenwhoare candidates for tonsillectomy. Rather, it is designed to assist clinicians by providing an evidence based framework for decision-making strategies. The guideline is not intended to replace clinical judgment or establish a protocol for all individuals with this condition and may not provide the only appropriate approach to managing this problem. Guidelinesareneverintendedtosupersedeprofessionaljudgmentrather,theymaybeviewedasarelative constraint on individual clinician discretion in a particular clinical circumstance. 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. Clinicians should always act and decide in a way that they believe will best serve their patients' interests and needs, regardless of guideline recommendations. Guidelines represent the best judgment of a team of experienced clinicians and methodologists addressing the scientific evidence for a particular topic.
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Thisguidelineisintendedtofocusonqualityimprovementopportunitiesjudgedmostimportantbytheworking group. It is not intended to be a comprehensive, general guide for managing 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 individual patients.
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Implementation of the Guideline

Description of Implementation Strategy The complete guideline is published as a supplement to OtolaryngologyHead and Neck Surgery, which will facilitate reference and distribution. A full-text version of the guideline will also be accessible free of charge for a limited time at www.entnet.org . The guideline will be presented to American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) members as a mini-seminar at the AAO-HNS annual meeting and OTO EXPO. Existing brochures and publications by the AAO-HNS will be updated to reflect the guideline recommendations. The panel identified several potential areas of the guideline in which obstacles to implementation might occur based on current practice patterns. Clinicians may be unfamiliar with the Paradise criteria for tonsillectomy, having relied on less stringent personal or organizational criteria to identify surgical candidates. Moreover, the importance of concurrent documentation to support the medical history is not always appreciated. Overcoming these beliefs will require teaching materials plus integration of this knowledge into existing continuing medical education venues for clinicians who assess tonsillectomy candidacy. Educational material will also be needed for caregivers of children with recurrent throat infection to explain the rationale for watchful waiting instead of earlier surgical intervention. Antibiotics are commonly used in the routine, perioperative care of children having tonsillectomy, despite convincing evidence of no beneficial impact on recovery (except for possibly reduced fever). Changing this behavior will require a paradigm shift, which is likely to be met with resistance based on long-established practices and anecdotal perceptions as to why antibiotics may be beneficial. Similarly, nonsteroidal anti-inflammatory drugs (NSAIDs) are used infrequently for pain control based on unfounded concerns about increased postoperative hemorrhage, which are not supported by systematic reviews of randomized trials. Conversely, codeine is often used after tonsillectomy despite no benefit over acetaminophen in randomized controlled trials plus a known adverse event profile that includes nausea and vomiting. Educational materials and brochures will be needed to reduce perioperative antibiotics, promote NSAIDs for pain control, and avoid codeine as a routine addition to acetaminophen. Several of the guideline recommendations deal with advocacy, education, or counseling. The panel opted for this approach, instead of recommending specific drugs or interventions, because in many cases high-quality, consistent evidence was lacking. Relevant statements in the guideline deal with managing the child with an abnormal polysomnography (PSG), anticipating possible persistence of sleep-disordered breathing and abnormal PSG after tonsillectomy, and involving the caregiver in postoperative pain management. Appropriate education materials and brochures will be needed to efficiently implement these strategies at the point of care. The guideline statement on post-tonsillectomy hemorrhage requests that clinicians who perform tonsillectomy determine their rate of primary and secondary post-tonsillectomy hemorrhage at least annually. Existing information systems at some hospitals or surgicenters may allow this to be readily accomplished, but for others, there will be an administrative burden in acquiring these data. This barrier to implementation suggests the need for a tool or data form to assist clinicians in gathering the relevant data.

Several of the guideline recommendations deal with advocacy, education, or counseling. The panel opted for this approach, instead of recommending specific drugs or interventions, because in many cases high-quality, consistent evidence was lacking. Relevant statements in the guideline deal with managing the child with an abnormal polysomnography (PSG), anticipating possible persistence of sleep-disordered breathing and abnormal PSG after tonsillectomy, and involving the caregiver in postoperative pain management. Appropriate education materials and brochures will be needed to efficiently implement these strategies at the point of care. The guideline statement on post-tonsillectomy hemorrhage requests that clinicians who perform tonsillectomy determine their rate of primary and secondary post-tonsillectomy hemorrhage at least annually. Existing information systems at some hospitals or surgicenters may allow this to be readily accomplished, but for others, there will be an administrative burden in acquiring these data. This barrier to implementation suggests the need for a tool or data form to assist clinicians in gathering the relevant data. Implementation Tools Patient Resources Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need Getting Better IOM Domain Effectiveness Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s) Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM, American Academy of Otolaryngology-Head and NeckSurgeryFoundation.Clinicalpracticeguideline:tonsillectomyinchildren.OtolaryngolHeadNeckSurg2011 Jan;144(1 Suppl):S1-30. [229 references] PubMed Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2011 Jan Guideline Developer(s) American Academy of Otolaryngology - Head and Neck Surgery Foundation - Medical Specialty Society Source(s) of Funding American Academy of OtolaryngologyHead and Neck Surgery Foundation Guideline Committee American Academy of OtolaryngologyHead and Neck Surgery (AAO-HNS) Foundation Guideline Development Panel Composition of Group That Authored the Guideline Panel Members: Reginald F. Baugh, MD, Department of Surgery, University of Toledo Medical Center, Toledo, Ohio, USA; Sanford M. Archer, MD, Division of Otolaryngology-Head & Neck Surgery, University of Kentucky Chandler Medical Center, Lexington, Kentucky, USA; Ron B. Mitchell, MD, Cardinal Glennon Children's Medical Center, Saint Louis University School of Medicine, St Louis, Missouri, USA; Richard M. Rosenfeld, MD, MPH, Department of Otolaryngology, SUNY Downstate Medical Center and Long Island College Hospital, Brooklyn, New York, USA; Raouf Amin, MD, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA; James J. Burns, MD, Department of Pediatrics, Baystate Children's Hospital, Springfield, Massachusetts, USA; David H. Darrow, MD, DDS, Department of Otolaryngology, Eastern Virginia Medical School, Norfolk, Virginia, USA; Terri Giordano, MSN, CRNP, CORLN, Division of Otolaryngology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; Ronald S. Litman, DO, Department of Anesthesiology and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Kasey K. Li, MD, DDS, Sleep Apnea Surgery Center, East Palo Alto, California, USA; Mary Ellen Mannix, MRPE, James's Project, Wayne, Pennsylvania, USA; Richard H. Schwartz, MD, Advanced Pediatrics, Vienna, Virginia, USA; Gavin Setzen, MD, Albany ENT & Allergy Services, PC, Albany, New York, USA; Ellen R. Wald, MD, Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA; Eric Wall, MD, MPH, Qualis Health, Seattle, Washington, USA; Gemma Sandberg, MA, The Cochrane ENT Disorders Group, Oxford, United Kingdom; and Milesh M. Patel, MS, American Academy of OtolaryngologyHead and Neck Surgery Foundation, Alexandria, Virginia, USA Financial Disclosures/Conflicts of Interest 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 OtolaryngologyHead and Neck Surgery (AAO-HNS) Foundation. Potential conflicts of interest for all panel members were compiled and distributed before the first conference call. After review and discussion of these disclosures, 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 industry 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. Disclosures

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 OtolaryngologyHead and Neck Surgery (AAO-HNS) Foundation. Potential conflicts of interest for all panel members were compiled and distributed before the first conference call. After review and discussion of these disclosures, 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 industry 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. Disclosures Raouf S. Amin, grant: Proctor and Gamble; Eric Wall, consultant: Anthem/Wellpoint (low-back pain pilot guideline), Senior Medical Director: Qualis Health Guideline Status This is the current release of the guideline. Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the American Academy of OtolaryngologyHead and Neck Surgery Foundation Web site Availability of Companion Documents A podcast of the guideline is available for download from the SAGE Journals Online Web site Patient Resources The following are available: Whattoexpectafteryourchildhastonsillectomy/adenoidectomysurgery.Factsheet.Alexandria(VA):American Academy of OtolaryngologyHead and Neck Surgery Foundation (AAO-HNS). 2 p. Electronic copies: Available in
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Portable Document Format (PDF) from the AAO-HNS Web site

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Tonsillectomyprocedures.Factsheet.Alexandria(VA):AmericanAcademyofOtolaryngologyHead and Neck .

Surgery Foundation (AAO-HNS). Electronic copies: Available from the AAO-HNS Web site
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MemberexpertQ&A:post-tonsillectomy pain management. Alexandria (VA): American Academy of OtolaryngologyHead and Neck Surgery Foundation (AAO-HNS). Electronic copies: Available from the AAO-HNS Web site .

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status This NGC summary was completed by ECRI Institute on March 14, 2011. The information was verified by the guideline developer on April 25, 2011. Copyright Statement Permission is granted to reproduce the aforementioned material in print and electronic format at no charge subject to the following conditions: 1.Ifanypartofthematerialtobeused(forexample,figures)hasappearedinourpublicationwithcreditor acknowledgement to another source, permission must also be sought from that source. If such permission is not obtained then that material may not be included in your publication/copies. 2.Suitableacknowledgementtothesourcemustbemade,eitherasafootnoteorinareferencelistattheendof your publication, as follows: "Reprinted from Publication title, Vol number, Author(s), Title of article, Pages No., Copyright (Year), with permission from American Academy of Otolaryngology-Head and Neck Surgery Foundation, Inc." 3.Reproductionofthismaterialisconfinedtothepurposeforwhichpermissionisherebygiven. 4.Thispermissionisgrantedfornon-exclusive world English rights only. For other languages please reapply separately for each one required.

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Disclaimer
NGC Disclaimer TheNationalGuidelineClearinghouse(NGC)doesnotdevelop,produce,approve,orendorsetheguidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusioncriteria.aspx. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer.