Treatment of Acute Otitis Media
Immediate Pain Management (First Priority for All Patients)
Initiate weight-based acetaminophen or ibuprofen immediately for every patient with acute otitis media, regardless of whether antibiotics will be prescribed. 1
- Analgesics provide symptomatic relief within the first 24 hours, whereas antibiotics provide no pain relief during the first 24 hours 1
- Continue pain medication throughout the acute phase as long as needed 1, 2
- Even after 3–7 days of antibiotic therapy, approximately 30% of children younger than 2 years still experience persistent pain or fever 1
Diagnostic Criteria (Required Before Treatment Decision)
Acute otitis media requires all three of the following elements: 1, 2
- Acute onset of symptoms (ear pain, irritability, fever)
- Middle ear effusion documented by impaired tympanic membrane mobility on pneumatic otoscopy, bulging, or air-fluid level
- Signs of middle ear inflammation: moderate-to-severe bulging of the tympanic membrane, new otorrhea not due to otitis externa, OR mild bulging with recent-onset ear pain (<48 hours) or intense erythema
Definition of Severe vs. Non-Severe Disease
Severe acute otitis media is defined by any of the following: 3, 1
- Moderate-to-severe otalgia
- Otalgia persisting ≥48 hours
- Temperature ≥39°C (102.2°F)
Non-severe disease: Mild otalgia <48 hours AND temperature <39°C 3, 1
Treatment Algorithm: Observation vs. Immediate Antibiotics
Children <6 Months
Prescribe immediate antibiotics for all children younger than 6 months with acute otitis media. 1, 2
Children 6–23 Months
Immediate antibiotics are required for: 3, 1, 2
- Severe symptoms (as defined above)
- Bilateral acute otitis media (even if non-severe)
Observation with close follow-up is appropriate for: 3, 1, 2
- Unilateral non-severe acute otitis media with reliable follow-up within 48–72 hours
- Requires joint decision-making with parents/caregivers
Children ≥24 Months (Including Adolescents)
Immediate antibiotics are required for: 3, 1, 2
- Severe symptoms (as defined above)
Observation with close follow-up is appropriate for: 3, 1, 2
- Non-severe acute otitis media (unilateral or bilateral) with reliable follow-up within 48–72 hours
- Requires joint decision-making with parents/caregivers
Requirements for Observation Strategy
When choosing observation without immediate antibiotics, all of the following must be in place: 1, 2
- A reliable follow-up mechanism within 48–72 hours (scheduled return visit or telephone contact)
- Provide a safety-net prescription to be filled only if symptoms worsen or fail to improve within 48–72 hours
- Educate caregivers that antibiotics must be started immediately if the child worsens or fails to improve
- Ensure caregivers understand most episodes are self-limited
First-Line Antibiotic Selection
Standard First-Line Therapy
High-dose amoxicillin (80–90 mg/kg/day divided into 2 doses, maximum 2 grams per dose) is the first-line antibiotic for most patients with acute otitis media. 3, 1, 2
- Amoxicillin achieves approximately 92% eradication of Streptococcus pneumoniae (including penicillin-resistant strains) 1
- Effective against the three most common pathogens: S. pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis 3, 1
When to Use Amoxicillin-Clavulanate Instead
Use amoxicillin-clavulanate (90 mg/kg/day of amoxicillin component + 6.4 mg/kg/day of clavulanate in 2 divided doses) as first-line therapy when any of the following are present: 3, 1, 2
- Amoxicillin use within the previous 30 days
- Concurrent purulent conjunctivitis (suggests H. influenzae infection)
- History of recurrent acute otitis media unresponsive to amoxicillin
- Attendance at daycare or high local prevalence of β-lactamase-producing organisms
Twice-daily dosing of amoxicillin-clavulanate causes significantly less diarrhea than three-times-daily dosing while maintaining equivalent efficacy. 1
Penicillin-Allergic Patients
Non-Severe (Non-IgE-Mediated) Penicillin Allergy
For patients with non-severe penicillin allergy, use oral second- or third-generation cephalosporins (cross-reactivity is approximately 0.1%, far lower than historically reported): 1, 2
- Cefdinir 14 mg/kg/day once daily (preferred for convenience) 1, 2
- Cefuroxime 30 mg/kg/day divided twice daily 1, 2
- Cefpodoxime 10 mg/kg/day divided twice daily 1, 2
Severe (IgE-Mediated) Penicillin Allergy
For patients with severe penicillin allergy, use: 1
- Intramuscular ceftriaxone 50 mg/kg once daily for 1–3 days
Do not use azithromycin as first-line therapy because pneumococcal macrolide resistance exceeds 40% in the United States, with bacterial failure rates of 20–25%. 1
Antibiotic Duration
Treatment duration depends on age and severity: 1, 2
- Children <2 years: 10-day course for all cases (regardless of severity) 1
- Children 2–5 years:
- Children ≥6 years:
Management of Treatment Failure
Reassessment Protocol
Reassess the patient at 48–72 hours if symptoms worsen or fail to improve. 3, 1, 2
Treatment Escalation Algorithm
If initially managed with observation: 1, 2
- Start high-dose amoxicillin (80–90 mg/kg/day)
- Switch to amoxicillin-clavulanate (90 mg/kg/day of amoxicillin + 6.4 mg/kg/day of clavulanate)
If amoxicillin-clavulanate fails: 3, 1
- Administer intramuscular ceftriaxone 50 mg/kg once daily for 3 consecutive days (a 3-day course is superior to a single-dose regimen) 1
After multiple treatment failures: 3, 1
- Perform tympanocentesis with culture and susceptibility testing to guide further therapy
- If tympanocentesis is unavailable, use clindamycin with adjunctive coverage for H. influenzae and M. catarrhalis (e.g., cefdinir, cefuroxime, or cefpodoxime)
- For multidrug-resistant S. pneumoniae serotype 19A, consider levofloxacin or linezolid only after consulting infectious disease and otolaryngology specialists
Antibiotics to Avoid in Treatment Failure
Do not use the following agents for treatment failures due to substantial resistance: 1
- Trimethoprim-sulfamethoxazole
- Erythromycin-sulfisoxazole
- Azithromycin or other macrolides
Post-Treatment Follow-Up and Middle Ear Effusion
After successful antibiotic treatment, middle ear effusion persists in: 1, 2
- 60–70% of children at 2 weeks
- 40% at 1 month
- 10–25% at 3 months
This post-treatment effusion (otitis media with effusion) requires monitoring but NOT antibiotics unless: 1
- Effusion persists >3 months with documented hearing loss
- Bilateral disease with documented hearing difficulty
- Structural abnormalities develop
Recurrent Acute Otitis Media
Recurrent acute otitis media is defined as: 1
- ≥3 episodes within 6 months, OR
- ≥4 episodes within 12 months with at least one episode in the preceding 6 months
Management of Recurrent Disease
Consider tympanostomy tube placement for children meeting recurrent acute otitis media criteria. 1
- Failure rates: 21% for tubes alone vs. 16% for tubes with adenoidectomy 1
- Adenoidectomy benefit is age-dependent and controversial 1
Long-term prophylactic antibiotics are NOT recommended for recurrent acute otitis media because the modest benefit does not justify the risk of antibiotic resistance. 1
Prevention Strategies
Modifiable risk factors to address: 1, 2
- Encourage breastfeeding for at least 6 months
- Reduce or eliminate pacifier use after 6 months of age
- Avoid supine bottle feeding
- Minimize daycare attendance patterns when possible
- Eliminate tobacco smoke exposure
- Pneumococcal conjugate vaccine (PCV-13)
- Annual influenza vaccination
Critical Pitfalls to Avoid
Antibiotics do NOT prevent complications: 33–81% of children who develop acute mastoiditis had received prior antibiotics 1
Do NOT prescribe antibiotics for: 1, 2
- Isolated tympanic membrane redness without middle ear effusion
- Otitis media with effusion (middle ear fluid without acute symptoms)
Do NOT use topical antibiotics for acute otitis media (these are indicated only for otitis externa or tympanostomy tube otorrhea) 1
Do NOT use corticosteroids (including prednisone) for acute otitis media as current evidence does not support their effectiveness 1