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Am Fam Physician. 2004;69(11):2713-2715

The Subcommittee on Management of Acute Otitis Media, which was convened by the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP), has released evidence-based clinical practice guidelines on the diagnosis and management of uncomplicated acute otitis media (AOM) in children between two months and 12 years of age. The subcommittee included primary care physicians and experts in the fields of otolaryngology, epidemiology, infectious disease, and general pediatrics. The guideline provides a specific definition of AOM and addresses pain management, initial observation versus antimicrobial treatment, appropriate choices of antimicrobials, and preventive measures. The full report was published in the May 2004 issue of Pediatrics.

The authors note that these guidelines are a framework for clinical decision-making and are not intended to replace clinical judgment or to establish a protocol for all children with this condition. The guideline only applies to otherwise healthy children without underlying conditions that may alter the natural course of AOM (i.e., anatomic abnormalities such as cleft palate, genetic conditions such as Down syndrome, immunodeficiencies, and the presence of cochlear implants), and children with a clinical recurrence of AOM within 30 days or AOM with underlying chronic otitis media with effusion.

Recommendation 1

To diagnose acute otitis media, the clinician should confirm a history of acute onset, identify signs of middle-ear effusion, and evaluate for the presence of signs and symptoms of middle-ear inflammation. (This recommendation is based on observational studies and a preponderance of benefit over risk; see accompanying table.)

Children with AOM typically present with a history of rapid onset of signs and symptoms, such as otalgia (pulling of the ear in an infant), irritability in an infant or toddler, otorrhea, or fever. A specific definition of acute otitis media is provided inthe accompanying table. The report states that clinical history alone is poorly predictive of the presence of AOM, especially in younger children.

The tympanic membrane may be visualized with the use of a pneumatic otoscopy, but visualization can be supplemented by tympanometry and/or acoustic reflectometry. Findings on otoscopy that predict AOM are fullness or bulging of the tympanic membrane combined with color and mobility.

It is difficult to distinguish between AOM and otitis media with effusion (OME). When OME is mistakenly identified as AOM, antibacterial agents may be prescribed unnecessarily. Common factors that may increase the uncertainty of a diagnosis of AOM include the inability to sufficiently clear the external auditory canal of cerumen, a narrow ear canal, and inability to maintain an adequate seal for successful pneumatic otoscopy or tympanometry.

A diagnosis of acute otitis media requires: (1) a history of acute onset of signs and symptoms, (2) the presence of middle-ear effusion, and (3) signs and symptoms of middle-ear inflammation.
Elements of the definition of acute otitis media are:
1. Recent, usually abrupt, onset of signs and symptoms of middle-ear inflammation and middle-ear effusion
2. The presence of middle-ear effusion that is indicated by any of the following:
  1. Bulging of the tympanic membraneb.

  2. Limited or absent mobility of the tympanic membranec.

  3. Air fluid level behind the tympanic membraned.

  4. Otorrhea

3. Signs or symptoms of middle-ear inflammation as indicated by either:
a. Distinct erythema of the tympanic membrane
b. Distinct otalgia (discomfort clearly referable to the ear[s] that results in interference with or precludes normal activity or sleep)

Recommendation 2

The management of AOM should include an assessment of pain. If pain is present, the clinician should recommend treatment to reduce pain. (This is a strong recommendation based on randomized clinical trials with limitations and a preponderance of benefit over risk.)

Many cases of AOM are associated with pain; however, physicians may see otalgia as a peripheral concern not requiring direct attention. The management of pain, especially during the first 24 hours of an episode of AOM, should be addressed regardless of the use of antibacterial agents. Physicians should select a treatment based on a consideration of benefits and risks and, when possible, incorporate the preferences of the parent or caregiver and the patient.

Recommendation 3A

Observation without the use of antibacterial agents in a child with uncomplicated AOM is an option for selected children based on diagnostic certainty, age, illness severity, and assurance of follow-up. (This option is based on randomized controlled trials with limitations and a relative balance of benefit and risk.)

This “observation option” for patients with AOM involves deferring antibacterial treatment of selected children for 48 to 72 hours and limiting management to symptomatic relief. The decision to observe or treat is based on the child's age, severity of illness, and diagnostic certainty. This option should be limited to otherwise healthy children six months to two years of age with non-severe illness at presentation and an uncertain diagnosis, and to children two years of age or older without severe symptoms at presentation or with an uncertain diagnosis. Observation provides these patients with an opportunity to improve without the use of antibacterial agents.

Recommendation 3B

If a decision is made to treat with an antibacterial agent, the clinician should prescribe amoxicillin for most children. (This recommendation is based on randomized clinical trials with limitations and a preponderance of benefit over risk.) When amoxicillin is used, the dosage should be 80 to 90 mg per kg per day. (This option is based on extrapolation from microbiologic studies and expert opinion, with a preponderance of benefit over risk.)

If the decision to treat with antibacterial agents is made, several medications are available that are clinically effective. The choice of a first-line treatment should be based on the anticipated clinical response and the microbiologic flora likely to be present. Amoxicillin is recommended as a first-line therapy for AOM because it is generally effective when used in sufficient doses against susceptible and intermediate resistant pneumococci. It also is safe, inexpensive, and has an acceptable taste and narrow microbiologic spectrum. If the patient is allergic to amoxicillin and the allergic reaction is not a type I hypersensitivity reaction, the physician can prescribe cefdinir, cefpodoxime, or cefuroxime. The optimal duration of therapy for patients with AOM is uncertain.

Recommendation 4

If the patient fails to respond to the initial management option within 48 to 72 hours, the clinician must reassess the patient to confirm AOM and exclude other causes of illness. If AOM is confirmed in the patient initially managed with observation, the clinician should begin antibacterial therapy. If the patient was initially managed with antibacterial agent(s), the clinician should change antibacterial agent(s). (This recommendation is based on observational studies and a preponderance of benefit over risk.)

During the early period of management with antibacterial agents, the patient may worsen slightly; however, the patient should stabilize within the first 24 hours of therapy and should begin to improve during the second 24-hour period. If the patient has not improved by 48 to 72 hours, there is another disease present or the chosen therapy was not adequate. The choice of antibacterial agent after initial failure of observation or first-line antibacterial therapy should be based on the likely pathogen(s) present or the physician's clinical experience. Once the patient has exhibited clinical improvement, follow-up is based on the usual clinical course of AOM.

Recommendation 5

Clinicians should encourage the prevention of AOM through reduction of risk factors. (This recommendation is based on strong observational studies and a preponderance of benefits over risks.)

The following factors are associated with early or recurrent AOM and are not amenable to change: genetic predisposition, male gender, premature birth, Native American or Inuit ethnicity, family history of recurrent otitis media, presence of siblings in the household, and low socioeconomic status.

During infancy and early childhood, the following interventions may reduce the incidence of recurrent AOM: reducing the incidence of respiratory tract infections by altering day care center attendance patterns; breastfeeding for at least the first six months; and avoiding supine bottle feeding and reducing or eliminating pacifier use in the second six months of life. The usefulness of these interventions is unclear.

Recommendation 6

No recommendations for complementary and alternative medicine (CAM) for treatment of AOM are made based on limited and controversial data.

Increasing numbers of parents and caregivers are using various forms of nonconventional treatment for their children. Clinicians should become more informed about forms of CAM, ask whether they are being used, and be ready to discuss potential benefits or risks. To date, there are no studies that conclusively show a beneficial effect of alternative therapies used for AOM.

editor's note: A “Point-of-Care Guide” on acuteotitis media in children will appear in the June 15, 2004, issue of American Family Physician.

Coverage of guidelines from other organizations does not imply endorsement by AFP or the AAFP.

This series is coordinated by Michael J. Arnold, MD, Assistant Medical Editor.

A collection of Practice Guidelines published in AFP is available at

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