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QUESTION: In children with acute otitis media (AOM) who are 6–24 months of age, how effective is amoxicillin in improving signs and symptoms?
Randomised (allocation concealed*), blinded (clinicians and parents),* placebo controlled trial with 6 week follow up.
53 general practices in the Netherlands.
240 children who were between 6 and 24 months of age (mean age 13 mo, 54% boys) and had AOM and ≥1 symptom of acute infection (fever, recent earache, general malaise, or recent irritability). Exclusion criteria were antibiotic therapy in the past 4 weeks, allergy to amoxicillin, compromised immunity, craniofacial abnormalities, or Down's syndrome. Follow up was 91% at 11 days and 88% at 6 weeks.
Patients were allocated to amoxicillin suspension, 40 mg/kg of body weight per day (n=117), or placebo (n=123) for 10 days. …