Health Care Guideline:
Diagnosis and Treatment of Otitis Media in Children
Ninth Edition
January 2008
I ICS
I NSTITUTE FOR C LINICAL
S YSTEMS I MPROVEMENT
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2
Symptoms Suggestive
of Otitis Media
Children Less Than
Three Years
- irritability
- fever
- night waking
- poor feeding
- running nose
- conjunctivitis
- balance problems
- hearing loss
- ear pain
Children Three Years
and Older
- ear pain
- ear drainage
- hearing loss
- ear popping
- ear fullness
- dizziness
Health Care Guideline:
Diagnosis and Treatment of Otitis Media in Children
Ninth Edition
January 2008
www.icsi.org
I ICS
I NSTITUTE FOR C LINICAL
S YSTEMS I MPROVEMENT
Copyright © 2008 by Institute for Clinical Systems Improvement 1
A = Annotation
5
Diagnostic Criteria for Acute
Otitis Media
• Middle ear effusion
(seen on exam and/or
confirmed by pneumatic
otoscopy) with either:
- local signs of
inflammation; or
- ear pain, ear drainage
irritability, restlessness,
or poor feeding
Diagnostic Criteria for Otitis
Media with Effusion
• Middle ear effusion
(seen on exam and/or
confirmed by pneumatic
otoscopy) or abnormal
tympanometry without signs
or symptoms of acute otitis
media
Acute Otitis Media
Caregiver or patient calls
with otitis media-related
symptoms or concerns
1
A
Symptoms
suggestive of otitis
media?
2
A
Triage for other
illnesses and/or
reassurance
3
A
Schedule appointment
4
A
Meets diagnostic
criteria for acute
otitis media?
5
A
Meets diagnostic
criteria for otitis media
with effusion?
no
no no
yes
13
A
Discuss prevention of
otitis media
6
A
yes
Initiate appropriate
treatment
7
A
History of recurrent
acute otitis media?
(3 episodes/6 months,
4 episodes/12 months)
8
A
no
yes
Acute otitis
media symptoms
resolved?
10
A
no
Out of guideline
12
yes
Refer to Otitis Media
with Effusion algorithm
(box 14)
yes
Schedule follow-up
11
Consider ENT referral
A
9
A
Diagnosis and Treatment of Otitis Media in Children
Ninth Edition/January 2008
Otitis Media with Effusion Algorithm
A = Annotation
www.icsi.org
2
Diagnosis of otitis
media with effusion
14
Is patient high
risk?
15
Further
assessment
yes
16
Is action
necessary?
17
Consider ENT
referral
yes
18
Discuss prevention,
treatment and
follow-up
19
no no
Otitis media
with effusion
symptoms
resolved?
20
Consider ENT
referral
no
21
Out of guideline
22
yes
A
A
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Algorithms and Annotations ....................................................................................... 1-14
Algorithm (Acute Otitis Media) ......................................................................................... 1
Algorithm (Otitis Media with Effusion) ............................................................................. 2
Foreword
Scope and Target Population ......................................................................................... 4
Clinical Highlights and Recommendations .................................................................. 4
Priority Aims ................................................................................................................. 4
Key Implementation Recommendations ....................................................................... 4
Related ICSI Scientific Documents .............................................................................. 4
Disclosure of Potential Conflict of Interest ................................................................... 5
Introduction to ICSI Document Development .............................................................. 5
Description of Evidence Grading.................................................................................. 6
Annotations ................................................................................................................... 7-14
Annotations (Acute Otitis Media) ............................................................................ 7-14
Annotations (Otitis Media with Effusion) ...................................................................14
Supporting Evidence.................................................................................................... 15-19
Brief Description of Evidence Grading ............................................................................ 16
References ...................................................................................................................17-19
Support for Implementation ..................................................................................... 20-25
Priority Aims and Suggested Measures ............................................................................ 21
Measurement Specifications .................................................................................. 22-23
Key Implementation Recommendations .......................................................................... 24
Knowledge Resources ...................................................................................................... 24
Resoures Available ........................................................................................................... 25
Table of Contents
Diagnosis and Treatment of Otitis Media in Children
Ninth Edition/January 2008
Work Group Leader
Leonard Snellman, MD
Pediatrics, HealthPartners
Medical Group
Work Group Members
Allergy
David Graft, MD
Park Nicollet Health
Services
ENT
William Avery, DO
Sanford Health
Barbara Malone, MD
Midwest ENT
Family Practice
Jeffrey Jenkins, MD
Sanford Health
Heather Krueger, MD
Quello Clinic, Ltd.
Carolyn Sparks, MD
University of MN Physicians
Pharmacy
Peter Marshall, PharmD
HealthPartners
Measurement/
Implementation Advisor
Teresa Hunteman, RRT,
CPHQ
ICSI
Facilitator
Melissa Marshall, MBA
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�
Foreword
Scope and Target Population
Children greater than 3 months to age 18.
Clinical Highlights and Recommendations
• A clinical examination is necessary to diagnose acute otitis media. Diagnosis should be made with
pneumatic otoscopy. (Annotations #4, 5)
• Educate parents on measures to prevent the occurrence of otitis media. (Annotation #6)
• Children with low risk should use a wait-and-see approach to treatment. (Annotation #7)
• Refer the patient to an ear, nose and throat specialist when the criteria are met. (Annotation #9)
Priority Aims
1. Increase the percentage of patients with a diagnosis of acute otitis media who were advised to "wait and
see."
2. Improve appropriate antibiotic usage for otitis media infections.
3. Improve caregivers' knowledge of symptoms suggestive of otitis media, appropriate indicators for a
provider visit, risk factors, and outcomes of otitis media.
4. Improve the percentage of patients with otitis media who receive an appropriate referral to an ear, nose
and throat specialist.
Key Implementation Recommendations
The following system changes were identified by the guideline work group as key strategies for health care
systems to incorporate in support of the implementation of this guideline.
1. Educate caregivers regarding the risks and benefits of antibiotic treatment, management of acute otitis
media symptoms and follow-up care.
2. When clinically appropriate, involve caregivers in the decision-making process by incorporating a
"watchful waiting" or "wait-and-see" approach to antibiotic use.
Related ICSI Scientific Documents
Related Guidelines
• Diagnosis and Treatment of Respiratory Illiness in Children and Adults
Diagnosis and Treatment of Otitis Media in Children
Ninth Edition/January 2008
Institute for Clinical Systems Improvement
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�
Disclosure of Potential Conflict of Interest
ICSI has adopted a policy of transparency, disclosing potential conflict and competing interests of all indi-
viduals who participate in the development, revision and approval of ICSI documents (guidelines, order
sets and protocols). This applies to all work groups (guidelines, order sets and protocols) and committees
(Committee on Evidence-Based Practice, Cardiovascular Steering Committee, Women's Health Steering
Committee, Preventive & Health Maintenance Steering Committee, Respiratory Steering Committee and
the Patient Safety & Reliability Steering Committee).
Participants must disclose any potential conflict and competing interests they or their dependents (spouse,
dependent children, or others claimed as dependents) may have with any organization with commercial,
proprietary, or political interests relevant to the topics covered by ICSI documents. Such disclosures will
be shared with all individuals who prepare, review and approve ICSI documents.
David Graft receives consulting/speaker fees and conference and travel support for asthma-related proj-
ects.
No other work group members have potential conflicts of interest to disclose.
Introduction to ICSI Document Development
This document was developed and/or revised by a multidisciplinary work group utilizing a defined process
for literature search and review, document development and revision, as well as obtaining and responding
to ICSI members.
For a description of ICSI's development and revision process, please see the Development and Revision
Process for Guidelines, Order Sets and Protocols at http://www.icsi.org.
Diagnosis and Treatment of Otitis Media in Children
Foreword Ninth Edition/January 2008
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�
Evidence Grading System
A. Primary Reports of New Data Collection:
Class A: Randomized, controlled trial
Class B: Cohort study
Class C: Non-randomized trial with concurrent or historical controls
Case-control study
Study of sensitivity and specificity of a diagnostic test
Population-based descriptive study
Class D: Cross-sectional study
Case series
Case report
B. Reports that Synthesize or Reflect upon Collections of Primary Reports:
Class M: Meta-analysis
Systematic review
Decision analysis
Cost-effectiveness analysis
Class R: Consensus statement
Consensus report
Narrative review
Class X: Medical opinion
Citations are listed in the guideline utilizing the format of (Author, YYYY [report class]). A full explanation
of ICSI's Evidence Grading System can be found at http://www.icsi.org.
Diagnosis and Treatment of Otitis Media in Children
Foreword Ninth Edition/January 2008
Institute for Clinical Systems Improvement
www.icsi.org
�
Algorithm Annotations
Acute Otitis Media Algorithm
1. Caregiver or Patient Calls with Otitis Media-Related Symptoms or
Concerns
Entrance into the guideline occurs when a caregiver or patient calls regarding an ill child /themselves whose
symptoms are suggestive of otitis media, or when a provider discovers findings of otitis media on exam.
2. Symptoms Suggestive of Otitis Media?
Generally
Restlessness, irritability, wakefulness and poor feeding usually associated with cold symptoms and/or conjunc-
tivitis (inflammation of the eye) are all general symptoms of acute otitis media (Ruuskanenen, 1994 [R]).
For Children Less Than Three Years of Age
Children less than three years old more often present with non-specific symptoms. Frequently, infants
and toddlers with otitis media have associated upper respiratory infection symptoms (Ruuskanenen, 1994
[R]). Symptoms include irritability, fever, night waking, poor feeding, cold symptoms, conjunctivitis and
occasional balance problems (Kempthrone, 1991 [R]).
Ear pulling without associated symptoms is usually not a symptom of otitis media (Baker, 1992 [C]).
For Children Ages Three and Older
Symptoms include earache, drainage from ears, hearing loss, ear popping, ear fullness or dizziness (Kemp-
throne, 1991 [R]).
3. Triage for Other Illnesses and/or Reassurance
For symptoms not suggestive of otitis, reassurance and anticipatory education of the symptoms of otitis should
be provided. If symptoms suggestive of another illness are described, refer to the appropriate guideline.
4. Schedule Appointment
Key Points:
• It is recommended that an appointment be made to accurately diagnose acute otitis
media.
While symptoms of acute otitis media are often dramatic, the illness is rarely an emergency. Most children
can be treated symptomatically through the night unless symptoms of a more serious illness are present.
Comfort measures can be discussed with parent/caretaker.
Comfort measures for the child with otitis media
• Hold or rock child.
• Acetaminophen or ibuprofen as appropriate for age and size of child.
Diagnosis and Treatment of Otitis Media in Children
Ninth Edition/January 2008
Institute for Clinical Systems Improvement
www.icsi.org
8
• Apply warm compresses to ear.
• Elevate the head by raising the head of the crib or use pillows for an older child.
• Wipe away drainage as it appears.
• For pain or irritability, analgesic ear drops can be used (Auralgan, mineral oil drops, or vegetable
oil drops such as olive oil). Analgesic ear drops are not to be given to a child with ventilating tubes
or if drainage in the ear canal is present.
Diagnosis of otitis media is made by exam. Diagnosis by phone should be avoided except in special circum-
stances (children with a history of multiple sets of ventilating tubes or children in high-risk categories such
as cleft palate or Down's syndrome who present with bloody or purulent drainage and who are well known
to the provider, and in whom follow-up is assured) (Pantell, 1990 [R]; Shelov, 1991 [R]).
5. Meets Diagnostic Criteria for Acute Otitis Media?
Key Points:
• Diagnosis for acute otitis media should be made with pneumatic otoscopy.
Middle-ear effusion (seen on examination and/or confirmed by pneumatic otoscopy) with:
• Local signs of inflammation (redness, bulging)
• Symptoms associated with acute otitis media
- otalgia (ear pain)
- otorrhea (ear drainage)
- irritability
- restlessness
- poor feeding
- fever
Acute otitis media is characterized by middle-ear effusion with acute inflammation. (The tympanic membrane
is usually full or bulging [decreased mobility by pneumatic otoscopy]. Color is usually red, yellow or cloudy.)
Symptoms may include otalgia, otorrhea, irritability, restlessness, poor feeding or fever. Tympanometry is
usually not necessary to establish the diagnosis of acute otitis media.
Tympanocentesis, while it is the gold standard of diagnosis, is not usually indicated in the treatment of acute
otitis media except for the relief of severe symptoms or when a culture is needed due to an associated, more
serious infection.
6. Discuss Prevention of Otitis Media
Parents/caretakers should be counseled about otitis media prevention. Elimination of controllable risk
factors should be encouraged whenever possible.
Otitis media prevention measures to discuss include:
• Encouraging breast-feeding (Aniansson, 1994 [B]; Duncan, 1993 [B])
• Feeding child upright if bottle fed
• Avoiding exposure to passive smoke (Hinton, 1988 [C]; Strachan, 1989 [D])
Diagnosis and Treatment of Otitis Media in Children
Algorithm Annotations Ninth Edition/January 2008
Institute for Clinical Systems Improvement
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• Tobacco cessation counseling
• Limiting exposure to numbers of children to the extent possible
• Teaching adults and children careful hand washing technique
• Limiting exposure to viral upper respiratory infections
• Avoid pacifier use beyond 10 months of age (Niemelä, 1995 [B])
• Ensure immunizations are up-to-date; including influenza and 7 valent conjugated polysaccharide
vaccine (PCV7)
7. Initiate Appropriate Treatment
Key Point:
• It is recommended that children with low risk be treated with a wait-and-see
approach.
• If antibiotic treatment is necessary, it is recommended that amoxicillin be the initial
treatment.
Treatment Options for Acute Otitis Media
Watch and wait
Low-risk children six months to two years without severe disease and an uncertain diagnosis should be treated
with oral and topical analgesics and may be observed for 48-72 hours. If symptoms do not resolve or are
worse, child should be rechecked and/or antibiotics prescribed. Parents may be provided with a prescrip-
tion at the initial visit and advised to wait 48 hours, filling the prescription only if symptoms worsen or do
not improve (Spiro, 2006 [A]). Clinicians must be available to communicate with parents regarding child's
symptoms during the observation time. The opportunity to share decision-making for treatment can lead
to higher parental satisfaction (Merenstein, 2005 [A]).
Low-risk children are defined as otherwise healthy, do not attend day care and have had no prior ear infec-
tions within the last month.
Severe disease is defined as fever greater than or equal to 39ºC in the past 24 hours and moderate to severe
otalgia. A diagnosis of acute otitis media meets any of the following criteria: sudden on