II. Precautions: Pitfalls
- Antihistamines and Decongestants are not useful
- Antibiotic dosages are often too low
- Most Otitis Media cases over age 2 years resolve without Antibiotics
- Alert patient families that child may have fever and Ear Pain for 48-72 hours despite Antibiotics
III. Risk factors: Treatment Failure
- Otitis Media within the last month
- Antibiotic within the last month
- Day Care attendance
- Bilateral Otitis Media
- Age less than 2 years old
- Age at first Otitis Media less than 6 months old
- Over 3 episodes Acute Otitis Media in last 6 months
- Beta-Lactamase producing H. Influenzae or M. catarrhalis
IV. Management: General
- Treat Otalgia with Acetaminophen and Ibuprofen
- No FDA approved Topical Anesthetics are available as of 2019
- With an intact drum, some providers use topical Lidocaine 0.5% or other Lidocaine preparations
- Mösges (2010) Arzneimittelforschung 60(7):427-31 +PMID: 20712132 [PubMed]
- Recheck ear exam in 3 months to confirm clearance of middle ear effusion (see below)
V. Protocol: Observation Protocol
- See Observation Protocol for Acute Otitis Media Management
- Strongly consider observation <48 hours of symptoms
- Age over 2 years OR
- Age 6-24 months if no severe symptoms
-
Antibiotics have few benefits beyond Placebo for ages 2-12 years old with middle ear infection
- Otitis Media Diagnosis is highly inaccurate
- No significant reduction in pain at 24 hours and 2 weeks compared with Placebo
- At 2-3 days, pain resolves with Antibiotics in 1 in 20 children
- Ibuprofen and Tylenol are typically sufficient for Ear Pain
- Antibiotics are also associated with adverse effects (Diarrhea, Vomiting, rash)
- Venekamp (2015) Cochrane Database Syst Rev (6):CD000219 [PubMed]
- Antibiotics have side effects (1 in 14 children)
- Diarrhea
- Rash
- Initial Antibiotics (versus observation, expectant management) does not reduce Otitis Media complication rates
- No difference in Tympanometry at 4 weeks
- Marginal difference in Tympanic Membrane Perforation (NNT 33 with Antibiotics)
- No difference in Otitis Media recurrence
- No proven reduction in Mastoiditis
- Grossman (2016) Pediatr Infect Dis 25(2): 162-5 [PubMed]
VI. Protocol: No Penicillin or Cephalosporin allergy
-
Antibiotic duration
- Age under 2 years: 10 day course
- Age 2 to 5 years: 7 day course
- Age >5 years: 5 day course (if severe symptoms, use 7 day course)
- First Line
- Amoxicillin 80-90 mg/kg/day PO divided twice daily for 10 days
- Dose up to 1000 mg three times daily
- If Penicillin Allergy
- Use Cefdinir (Omnicef) or Azithromycin (higher Antibiotic Resistance rates)
- May consider other Cephalosporins from second-line list below
- Move to third-line therapy if persistent severe findings after 48-72 hours of Antibiotics
- If unable to use Cephalosporins (due to allergy)
- Use alternative agents as shown below (e.g. Azithromycin)
- Indications for moving to second-line treatment
- Persistent symptoms with bulging, erythematous TM after 48-72 hours on first-line treatment
- Antibiotics in last 30 days
- Concurrent Otitis Media with purulent Conjunctivitis
- Amoxicillin 80-90 mg/kg/day PO divided twice daily for 10 days
- Second Line (10 day course)
- Amoxicillin with clavulanate (Augmentin) 90 mg/kg/day divided twice daily for 10 days (preferred)
- Dose up to 2000/125 mg of XR orally twice daily
- Cefdinir (Omnicef) 14 mg/kg/day divided one to two times daily for 10 days (preferred in Penicillin allergic)
- Dose up to 300 mg every 12 hours or 600 mg every 24 hours
- Cefuroxime (Zinacef, Ceftin) 30 mg/kg/day divided twice daily (up to 500 mg twice daily) for 10 days
- Cefprozil (Cefzil) 30 mg/kg/day divided twice daily (up to 500 mg twice daily) for 10 days
- Cefpodoxime (Vantin) 10 mg/kg divided twice daily (up to 200 mg twice daily) for 10 days
- Amoxicillin with clavulanate (Augmentin) 90 mg/kg/day divided twice daily for 10 days (preferred)
- Third Line
- Strongly consider Tympanocentesis for Bacterial culture
- Ceftriaxone (Rocephin) 50 mg/kg IM daily for 3 days
- Clindamycin 30-40 mg/kg/day divided four times daily for 10 days
- Fails to cover HaemophilusInfluenzae
- Recurrent Otitis Media
- See Tympanostomy Tube for indications
VII. Protocol: Agents if Penicillin and Cephalosporin Allergy
- Consider Tympanocentesis
- Clindamycin (Cleocin) 30-40 mg/kg/day (max 1800 mg) divided four times daily for 10 days
- Macrolide Antibiotics (High Bacterial resistance rate)
- Erythromycin
- Clarithromycin (Biaxin) 15 mg/kg/day divided twice daily for 10 days
- Azithromycin (Zithromax)
- One dose of Azithromycin XR (Zmax) at 30 mg/kg (up to 1500 mg) or
- Three days of Azithromycin at 20 mg/kg/day once daily (up to 500 mg/day) or
- This high dose approached Augmentin efficacy in one study
- Arrieta (2003) Antimicrob Agents Chemother 47:3179 [PubMed]
- Azithromycin 10 mg/kg (max: 500 mg) day 1, then 5 mg/kg/day (max 250 mg) for 5 days
-
Fluoroquinolones (avoid under age 16 years)
- Levofloxacin (Levaquin) 20 mg/kg/day divided twice daily up to 750 mg every 24 hours
- Moxifloxacin (Avelox) 400 mg orally every 24 hours
VIII. Protocol: Topical agents if patent Tympanostomy Tubes
- See Tympanostomy Tube
- Do not use Cipro HC Otic (not sterile)
- Avoid all cortisporin products (including suspension)
- Combinations with steroid result in faster resolution but are much more expensive
- Ofloxacin 0.3% (Floxin Otic) 5 drops (10 drops if over age 12) twice daily for 7 days
- Ciprofloxacin ophthalmic (ciloxan drops) 4 drops twice daily for 7 days
- Ciprofloxacin 0.3% with Dexamethasone 0.1% (Ciprodex) 4 drops in ear twice daily for 7-10 days
- Ciprofloxacin 0.3% with Fluocinolone Acetonide 0.025% (Otovel) 0.25 ml vial in ear twice daily for 7 days
IX. Follow-up: Persistent Middle Ear Effusion (Otitis Media with Effusion)
- Natural course
- At 2 weeks: 70% have persistent effusion
- At 4 weeks: 40%
- At 2 months: 20%
- At 3 months: 10%
- Persistent effusion at 3 months
- See Otitis Media with Effusion
- Consider otolaryngology Consultation (including consideration for Tympanostomy Tube)
- If Tympanostomy Tubes not placed, recheck effusion every 3 months
X. Precautions: Higher risk populations
- Infants under 8 weeks of age
- Associated with increased complications from Otitis Media
- Otitis Media in age <8 weeks may be complicated by Sepsis, Meningitis, Mastoiditis
- All febrile infants under 4 weeks undergo Neonatal Sepsis evaluation (regardless of Otitis Media presense)
- Infants <2 weeks commonly have GBS, Gram Negative Bacteria and Chlamydia trachomatis in middle ear
- Adults with recurrent otitits media (>2 episodes/year) or persistent Otitis Media (>6 weeks)
- Consider mechanical obstruction
- Consider naspharyngeal mass (especially blocking the eustachian tube)
XI. Prevention
- Prevnar 13 Vaccine
- Influenza Vaccine
- Breast Feeding
- Avoid Tobacco smoke exposure
- Avoid propped bottles
- Reduce or eliminate Pacifier use in age >6 months old
- AVOID Prophylactic Antibiotics
- Reduce infections by 1 per year
- Increase Antibiotics resistance
XII. References
- (2019) Sanford Guide, accessed on IOS 11/19/2019
- (2016) Presc Lett 23(12): 68
- (2022) Presc Lett 29(2): 9
- Thomas and Kosoko (2022) Crit Dec Emerg Med 36(12): 12-3
- Aronovitz (2000) Clin Ther 22:29-39 [PubMed]
- Culpepper (1997) JAMA 278:1643-5 [PubMed]
- Del Mar (1997) BMJ 314:1526-9 [PubMed]
- Dowell (1998) Am Fam Physician 58:1113-23 [PubMed]
- Gaddey (2019) Am Fam Physician 100(6): 350-6 [PubMed]
- Harmes (2013) Am Fam Physician 88(7):435-40 [PubMed]
- Hoppe (1998) Am J Health Syst Pharm 55:1881-97 [PubMed]
- Lieberthal (2013) Pediatrics 131(3): e964-99 [PubMed]
- Pichichero (2000) Ann Otol Rhinol Laryngol 109:2-10 [PubMed]
- Pichichero (2000) Am Fam Physician 61(8):2410-6 [PubMed]