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Guideline Summary
Guideline Title
Otitis media: acute otitis media (AOM) and otitis media with effusion (OME).
Bibliographic Source(s)
Medical Services Commission. Otitis media: acute otitis media (AOM) and otitis media with effusion (OME). Victoria (BC): British Columbia Medical Services Commission; 2010 Jan 1. 7 p. [31 references]
Guideline Status

This is the current release of the guideline.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • August 1, 2013 – Acetaminophen External Web Site Policy: The U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.

Scope

Disease/Condition(s)
  • Acute otitis media (AOM)
  • Otitis media with effusion (OME)

Note: AOM is defined as the presence of inflammation in the middle ear accompanied by the rapid onset of signs and symptoms of an ear infection. OME is defined as the presence of fluid in the middle ear without signs and symptoms of an ear infection.

Guideline Category
Diagnosis
Management
Prevention
Risk Assessment
Treatment
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Otolaryngology
Pediatrics
Intended Users
Physician Assistants
Physicians
Guideline Objective(s)

To describe the diagnosis and management of children over the age of 6 months with acute otitis media (AOM) and otitis media with effusion (OME)

Target Population

Otherwise healthy children over the age of 6 months presenting with acute otitis media (AOM) or otitis media with effusion (OME)

Note: This guideline does not include children with craniofacial abnormalities, immune deficiencies, complications of AOM (e.g., mastoiditis, facial paralysis, etc.) or serious underlying disease.

Interventions and Practices Considered

Prevention/Risk Assessment

  1. Hand washing
  2. Evaluation of risk factors: environmental tobacco smoke, daycare attendance, pacifier use, bottle feeding in a supine position
  3. Breastfeeding
  4. Immunizations

Diagnosis

  1. Pneumatic otoscopy (not routinely preformed)
  2. Distinguishing between acute otitis media (AOM) and otitis media with effusion (OME)

Management

  1. Aggressively managing pain
  2. Treating with antibiotics if unwell after 48-72 hours of analgesics
  3. Five days of therapy (for children 2 years and over)
  4. Re-examination of child
  5. Referral to otolaryngologist for complications or formal hearing evaluation
  6. Observation at 3 month intervals until resolution of effusion
  7. Surgical treatment (e.g., tympanostomy tube insertion)
Major Outcomes Considered
  • Ear pain
  • Acute infection
  • Hearing loss and impaired development
  • Surgery

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Evidence was obtained through a systematic review of peer-reviewed literature (up to November 2009) using the databases MEDLINE, PubMed, EBSCO, Ovid, and the Cochrane Collaboration's Database for Systematic Reviews. Search terms: acute otitis media, otitis media with effusion, antibiotics and otitis media, diagnosis and treatment, topical antibiotics, watchful waiting, breastfeeding, tobacco. Clinical practice guidelines from other jurisdictions for acute otitis media, otitis media with effusion, antibiotics and otitis media, diagnosis and treatment, watchful waiting were also reviewed (up to November 2009).

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Not stated
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

This is an evidence based clinical guideline for general practitioners including consensus statements when evidence is not available. It is based on scientific evidence current as of the Effective Date.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

This guideline was approved by the British Columbia Medical Association and adopted by the Medical Services Commission.

Recommendations

Major Recommendations

Prevention and Risk Factors

Hand washing prevents colds and flu - the major risk factor for otitis media. Other risk factors for acute otitis media (AOM) include: environmental tobacco smoke, daycare attendance, pacifier use, and bottle feeding in a supine position. Breastfeeding or immunizations may offer some protection against AOM.

Diagnosis and Investigation

Children with AOM present with combinations of ear pain (otalgia), loss of landmarks and an opaque, bulging, inflamed tympanic membrane on direct otoscopy. Additional non-specific symptoms include: irritability, fever, night waking, poor feeding, cold symptoms, conjunctivitis and occasional balance problems.

Otitis media with effusion (OME) is defined as the presence of fluid in the middle ear without acute infection. The child may have ear discomfort but the ear is not acutely painful. The fluid may range from clear to opaque. Decreased mobility on pneumatic otoscopy supports the diagnosis of OME.

Although pneumatic otoscopy is helpful in the diagnosis of AOM, it is not routinely performed as it may elicit severe pain.

It is important to distinguish between AOM and OME. Ear discomfort, a red tympanic membrane, or fever alone are not specific diagnostic criteria for AOM. Pneumatic otoscopy is a useful tool in diagnosing OME.

If acute otitis media (AOM) is diagnosed or suspected, proceed to Part I. If otitis media with effusion (OME) is diagnosed or suspected, proceed to Part II.

Part I: Acute Otitis Media

Management of AOM

For most children, antibiotics are not warranted. Spontaneous resolution of AOM is to be expected in approximately 80 per cent of children.

  • AOM does not always require antibiotics, providing that good follow up is provided.
  • Aggressively manage pain with adequate systemic analgesics (not acetylsalicylic acid [ASA]).
  • If a child is significantly unwell after 48-72 hours of analgesics, treat with antibiotics regardless of age.
  • Decongestants, antihistamines and steroids are not beneficial in the treatment of AOM.

Pharmacological Management

Table. Initial Treatment of AOM for Children Over 6 Months of Age

Patient Type Therapy Dose Comments
Otherwise healthy with mild symptoms
(see comments)
Acetaminophen 10-15 mg/kg/dose PO
Q4H prn
(max 75 mg/kg/day)
For ages 6-24 months, observation with the use of systemic analgesics without the use of antibacterial agents is an option for selected children with uncomplicated AOM, based on diagnostic certainty, age, illness severity and assurance of follow-up.

If older than 24 months, most cases of AOM resolve and do not require antibiotics, as long as symptoms are manageable with systemic analgesics, the child has access to re-evaluation at 48 hours and symptoms do not persist.

If signs and symptoms of AOM persist in spite of using systemic analgesics for 48 to 72 hours, reassess and consider treatment with antibiotics.
Ibuprofen 5-10 mg/kg/dose PO Q6-8H prn
(max 40 mg/kg/day)
No daycare attendance and no antibiotics within 90 days Amoxicillin Standard Dose:
40-45 mg/kg/day PO div tid
  • ≥2 years: treat for 5 days
  • <2 years: treat for 10 days
High risk factors increase the risk of resistant Streptococcus pneumoniae (S. pneumoniae)
Daycare attendance and antibiotics within 90 days Amoxicillin High Dose:
80-90 mg/kg/day PO div tid
  • ≥2 years: treat for 5 days
  • <2 years: treat for 10 days
Amoxicillin retains the best activity of all oral β-lactam agents against S. pneumoniae, including penicillin intermediate resistant strains
β-lactam allergy* The incidence of cephalosporin cross-reactivity with penicillin allergy is less than 2%. Consider allergy testing when infection resolves to confirm penicillin allergy.
Penicillin allergy
  • Non-anaphylactic
Cefuroxime axetil 30 mg/kg/day PO div bid
  • ≥2 years: treat for 5 days
  • <2 years: treat for 10 days
Due to poor taste of cefuroxime suspension, recommend tablets if possible, can be crushed and put in to a palatable fluid
or Cefprozil 30 mg/kg/day PO div bid
  • ≥2 years: treat for 5 days
  • <2 years: treat for 10 days
Compared to cefuroxime, liquid cefprozil has a better taste but inferior coverage of Haemophilus and Penicillin Intermediate resistance - S. pneumoniae
Penicillin allergy
  • Anaphylactic or
  • Cephalosporin allergy
Clarithromycin 15 mg/kg/day/ div bid for 10 days** TMP/SMX and macrolides are inferior options due to high resistance rates and clinical failure rates

Consider referral to otolaryngologist for tympanocentesis
or
TMP/SMX
6-12 mg TMP/kg/day PO div bid
  • ≥2 years: treat for 5 days
  • <2 years: treat for 10 days
or
Azithromycin
10 mg/kg/day PO on the first day and 5 mg/kg/day PO for 4 days

div = divided; TMP/SMX = trimethoprim/sulfamethoxazole

*β-lactam = Any of a class of broad-spectrum antibiotics that are structurally and pharmacologically related to the penicillins and cephalosporins.

**10 days of therapy with macrolides is preferred because of lower activity in this class of medication compared to the beta lactams

Duration of Therapy for AOM

Five days of therapy has equal efficacy to the standard ten day regimen in children with uncomplicated AOM and is recommended in children two years of age and over. For children less than two years of age or those who present with perforation of the tympanic membrane, ten days of antibiotic therapy are still recommended. Failure of initial treatment of AOM with antibiotics is defined as the persistence or worsening of moderately severe symptoms (pain and fever) after three to five days of antibiotic therapy with findings of continued pressure and inflammation (bulging) behind the tympanic membrane.

Table. Failure of Initial Treatment of AOM

Patient Type Therapy Dose Comments
Failure of standard dose amoxicillin Amoxicillin

PLUS
40-45 mg/kg/day PO div tid for 10 days The combination is recommended to provide a high dose of amoxicillin (for penicillin intermediate resistance S. pneumoniae) and regular dose of amoxicillin-clavulanate (for coverage of β-lactamase producing H. influenzae and M. catarrhalis) without excessive clavulanate (>10 mg/kg/day) – which may lead to increased incidence of diarrhea
Amoxicillin – clavulanate (use 7:1 formulation)*
(2 separate prescriptions should be given)
45 mg/kg/day PO div tid for 10 days (based on amoxicillin component)
Failure of high dose amoxicillin Amoxicillin – clavulanate (use 4:1 formulation)* 40 mg/kg/day PO div tid for 10 days (based on amoxicillin component) Due to poor taste of cefuroxime axetil suspension, recommend tablets if possible, can be crushed and put in to a palatable fluid
or Cefuroxime axetil 30 mg/kg/day PO div bid for 10 days
or Cefprozil 30 mg/kg/day po div bid for 10 days
β - lactam (penicillin) allergy Clarithromycin 15 mg/kg/day PO div bid for 10 days Therapeutic options for these patients are very limited. Consider referral to otolaryngologist for tympanocentesis.

Macrolides and TMP/SMX are less efficacious than amoxicillin-clavulanate. There is significant macrolide resistance in S. pneumoniae
or TMP/SMX 6-12 mg TMP/kg/day PO div bid for 10 days
or Azithromycin 10 mg/kg PO first day then 5 mg/kg/day x 4 days

*There are two formulations of amoxicillin:clavulanate, 4:1 and 7:1 ratios. Higher doses of clavulanate increase the likelihood of GI side effects. If a patient has failed standard dose amoxicillin, these patients should receive 2 prescriptions: one for amoxicillin and one for the 7:1 ratio of amoxicillin:clavulanate. This combination gives a high dose of amoxicillin plus a therapeutic dose of beta lactamase inhibitor (clavulanate) which is low enough to reduce the risk of diarrhea. If a patient has failed high dose amoxicillin, they are more likely to have an illness caused by a beta lactamase producing bacteria, hence the 4:1 ratio of amoxicillin:clavulanate maximizes the amount of beta lactamase inhibitor (clavulanate) but using this product increases the risk of diarrhea.

Table. Agents NOT Recommended for AOM

Cephalexin No activity against Penicillin intermediate resistant S. pneumoniae
No activity against Haemophilus influenzae/Moraxella catarrhalis
Cefaclor No activity against Penicillin intermediate resistant S. pneumoniae
Marginal activity against Haemophilus influenzae/Moraxella catarrhalis
Cefixime No activity against Penicillin intermediate resistant S. pneumoniae
Excellent activity against Haemophilus influenzae
Ceftriaxone Routine use of this agent is not recommended due to potential for increased resistance to 3rd generation cephalosporins. May be an option in severe cases who have failed therapy, in immunosuppressed patients or neonates. NB: 3 days of IM/IV therapy recommended. (single dose not as effective in eradicating penicillin resistant S. pneumoniae)
Clindamycin No activity against Haemophilus/Moraxella spp. (Clindamycin may be an option for S. pneumoniae in severe penicillin allergic patients)
Erythromycin Poor activity against Haemophilus influenzae
Significant macrolide resistance in S. pneumoniae

On Going Care

  • Re-examine child if he/she is not improving within 48 to 72 hours.
  • If perforation occurs, this is not a serious complication as this generally heals without intervention. Water and objects such as cotton tip swabs should be kept out of the ear canal. There is no need to refer to an otolaryngologist for a simple rupture of the tympanic membrane. Manage as for AOM. Refer to an otolaryngologist if the perforation does not heal in six weeks.
  • Routine follow-up examination is not required until three to six months post-infection to evaluate OME.
  • Refer to an otolaryngologist urgently if complications occur such as: facial paralysis or mastoiditis (symptoms include fever and persistent, throbbing otalgia; signs include purulent otorrhea, redness, swelling, tenderness, and fluctuation over the mastoid process; the pinna is typically displaced laterally and inferiorly).
  • Refer to an otolaryngologist electively if three or more episodes of AOM occur in six months or four episodes of AOM occur in 12 months.

Part II: Otitis Media with Effusion (OME)

OME is associated with ear discomfort and recurrences of acute otitis media (AOM) and often follows an episode of AOM. Transient hearing loss is frequently associated with OME. Spontaneous resolution of OME occurs in 90 per cent of patients within three months of infection.

On Going Care

When OME has been present for at least 12 weeks, observation is advised at 3 month intervals until the resolution of effusion. If there are concerns of 'significant' hearing loss or structural abnormalities of the tympanic membrane, a formal hearing evaluation and referral to an otolaryngologist is recommended.

Note: Decongestants, antihistamines, steroids, and antibiotics are not recommended in the treatment of OME.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

This is an evidence based clinical guideline for general practitioners including consensus statements when evidence is not available. The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Effective diagnosis and management of acute otitis media (AOM) and otitis media with effusion (OME)

Potential Harms
  • Trimethoprim/sulfamethoxazole (TMP/SMX) and macrolides are inferior options due to high resistance rates and clinical failure rates.
  • Excessive clavulanate may lead to increased incidence of diarrhea.
  • Macrolides and TMP/SMX are less efficacious than amoxicillin-clavulanate. There is significant macrolide resistance in S. pneumoniae.

Qualifying Statements

Qualifying Statements

The Clinical Practice Guidelines (the "Guidelines") have been developed by the Guidelines and Protocols Advisory Committee on behalf of the Medical Services Commission. The Guidelines are intended to give an understanding of a clinical problem, and outline one or more preferred approaches to the investigation and management of the problem. The Guidelines are not intended as a substitute for the advice or professional judgment of a health care professional, nor are they intended to be the only approach to the management of clinical problems.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Mobile Device Resources
Patient 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
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Medical Services Commission. Otitis media: acute otitis media (AOM) and otitis media with effusion (OME). Victoria (BC): British Columbia Medical Services Commission; 2010 Jan 1. 7 p. [31 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Jan 1
Guideline Developer(s)
Medical Services Commission, British Columbia - State/Local Government Agency [Non-U.S.]
Source(s) of Funding

Medical Services Commission, British Columbia

Guideline Committee

Guideline and Protocols Advisory Committee

Composition of Group That Authored the Guideline

Not stated

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the British Columbia Ministry of Health Web site External Web Site Policy.

The guideline is also available for mobile devices from the British Columbia Ministry of Health Web site External Web Site Policy.

Availability of Companion Documents

None available

Patient Resources

The following is available:

  • Otitis media in children. A guide for parents. Victoria (BC): British Columbia Medical Services Commission; 2010 Jan 1. 2 p. Electronic copies: Available in Portable Document Format (PDF) from the British Columbia Ministry of Health Web site External Web Site Policy.

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 January 31, 2013. The information was verified by the guideline developer on March 20, 2013. This summary was updated by ECRI Institute on October 28, 2013 following the U.S. Food and Drug Administration advisory on Acetaminophen.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

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