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#42 Children with Acute Otitis Media: Benefits and Risks of Antibiotics

In children with acute otitis media (AOM) what are benefits and risks of antibiotics?

Although most children will recover from acute otitis media without complications, antibiotics will improve outcomes for 1 in 3 to 1 in 10, depending on outcome and complicating factors. Antibiotics will cause adverse events, particularly diarrhea, in up to 1 in every 5.

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Randomized Controlled Trial (RCT):1 319 patients, age 6-35 months. 
  • Amoxicillin/clavulanate (40/5.7 mg/kg/day) versus placebo, divided BID x7 days 
    • Treatment failure day eight: 19% (antibiotic) versus 45% (placebo), Number Needed to Treat (NNT)=4. 
    • Reduced absenteeism for child (day-care) and parent (work), more fever resolution, less contra-lateral AOM, fewer rescue treatments, etc. 
  • Antibiotics increased adverse events: Eczema Number Needed to Harm (NNH)=19, any diarrhea NNH=5 and for “a lot” of diarrhea NNH=12. 
RCT:2 291 patients, age 6-23 months. 
  • Amoxicillin/clavulanate (90/6.4 mg/kg/day) versus placebo, divided BID x10 days. 
    • Clinical failure day 4-5: 4% versus 23%, NNT=6. 
    • Day 10-12: 16% versus 51%, NNT=3. 
  • Antibiotics increased adverse events: Diarrhea NNH=10, diaper rash NNH=7. 
RCT:3 84 patients, 85% ≤5 years old. 
  • Amoxicillin/clavulanate (40 mg/kg/day) versus placebo, divided BID x7 days. 
    • Resolution of middle ear effusion: 18.9 versus 32.6 days.   
    • Ear ache five days after initiation: 0% versus 17%, NNT=6. 
  • Three systematic reviews:4-6 7-15 RCTs (2,079-4,500 patients), antibiotic versus placebo, similar results. 
    • Persistent pain:6 At 24 hours no difference; At 2-3 days NNT=24; At 4-7 days NNT=17. 
    • Treatment success at 14 days:4 NNT=9. 
    • Less perforation and contralateral infection.6 
    • Vomiting, diarrhea, or rash:6 NNH=14. 
  • Natural history: 70% of untreated children have resolution at 7-14 days.1,2,4 
  • Poor Prognostic Indicators: Bilateral Otitis Media,2,7 age <24 months,7 exposure to more children (day-care),2 and more severe symptom scores.2 
  • Types of antibiotics: No reliable difference in the efficacy of antibiotics studied.4   
    • Amoxicillin is the most commonly studied and recommended.4,8    
  • Delayed versus immediate prescriptions:  
    • Four studies, two found no difference and two found immediate prescriptions superior (NNT=6-7).4  
    • Delayed prescriptions may increase patient dissatisfaction.9 
updated mar 10 2015 by braiden

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  • Christina Korownyk MD CCFP
  • G. Michael Allan MD CCFP

1. Tähtinen PA, Laine MK, Huovinen P, et al. N Engl J Med. 2011; 364:116-26.

2. Hoberman A, Paradise JL, Rockette HE, et al. N Engl J Med. 2011; 364:105-15.

3. Tapiainen T, Kujala T, Renko M, et al. JAMA Pediatr. 2014; 168(7):635-41.

4. Coker TR, Chan LS, Newberry SJ, et al. JAMA. 2010; 304(19):2161-9.

5. Gisselsson-Solen M. Int J Pediatr Otorhinolaryngol. 2014; 78(8):1221-7.

6. Venekamp RP, Sanders S, Glasziou PP, et al. Cochrane Database Syst Rev. 2013; 1:CD000219.

7. Rovers MM, Glasziou P, Appelman CL, et al. Pediatrics. 2007; 119;579-85.

8. S Forgie, G Zhanel, J Robinson. Paediatr Child Health. 2009; 14(7):457-60.

9. Spurling GK, Del Mar CB, Dooley L, et al. Cochrane Database Syst Rev. 2013; 4:CD004417.

Authors do not have any conflicts of interest to declare.