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QUESTION: In children with acute otitis media and who are at risk of a poor outcome, what is the comparative effectiveness of immediate and delayed antibiotics?
Design
Randomised {allocation concealed*}†, {unblinded}†,* trial with 3 days of follow up. This study was a secondary analysis of a previously published randomised controlled trial‡.
Setting
Primary care setting in the Southampton area, UK.
Patients
285 children between 6 months and 10 years of age with acute otitis media and information on symptom duration. Exclusion criteria were pink drum alone, otitis media with effusion and chronic suppurative otitis media, serious chronic disease, use of antibiotics in previous 2 weeks, previous complications, or systemic ill health. Follow up was 90%.
Intervention
Children were assigned to immediate antibiotics (amoxicillin or erythromycin) {n=135}† or …
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