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Therapeutics
Amoxicillin resolved otitis media symptoms in young children better than did placebo at day 4 but not at day 11

https://doi.org/10.1136/ebm.5.5.149

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

    Design

    Randomised (allocation concealed*), blinded (clinicians and parents),* placebo controlled trial with 6 week follow up.

    Setting

    53 general practices in the Netherlands.

    Patients

    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.

    Intervention

    Patients were allocated to amoxicillin suspension, 40 mg/kg of body weight per day (n=117), or placebo (n=123) for 10 days. …

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    Footnotes

    • Sources of funding: Netherlands Organisation for Scientific Research. Nasivin nose drops supplied by E Merck Nederland BV.

    • For correspondence: Dr R A Damoiseaux, Department of General Practice, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, the Netherlands. Fax +31 30 2539028.

    • ↵* See glossary.

    • ↵† p Values calculated from data in article.