antibiotics in otitis media (in children aged <=2 years)

Last reviewed 03/2022

There is evidence (1) that treatment with amoxicillin in children with <= 2 years of age with acute otitis media, leads to a resolution of more symptoms after 4 days of treatment. However, by day 11, the treatment groups did not differ.

The trial is summarised below:

• trial design - randomised, placebo controlled, blinded trial. There was a 6 week follow-up
• patient - 240 children; aged between 6 months and 24 months and had acute otitis media plus >=1 symptom of acute infection (recent earache, fever, recent irritability, or general malaise); exlusion criteria were allergy to amoxycillin, antibiotic treatment in the past 4 weeks, immunocompromised patient, Down's syndrome or craniofacial abnormalities
• intervention - patients were either treated with amoxycillin or placebo for 10 days
• outcome measures - persistent symptoms at day 4; clinical treatment failure at day 11; middle ear effusion at 6 weeks; adverse effects
• conclusions - treatment with amoxycillin leads to more resolution of symptoms after day 4. There was no significant difference between the groups for clinical treatment failure at day 11, for the prevalence of middle ear effusion at 6 weeks, or adverse effects

Reference:

1. Damoiseaux RA, van Balen FA, Hoes AW et al. Primary care based randomised, double blind trial of amoxycilling versus placebo for acute otitis media in children aged under 2 years of age. BMJ 2000; 5;320 (5): 350-4.