Delayed prescribing of antibiotics increased duration of acute otitis media symptoms in children but reduced diarrhoea

DesignRandomised (unclear allocation concealment), unblinded, controlled trial with about 1 week of follow up.SettingGeneral practices in south west UK.Patients315 children aged 6 months to 10 years (59% >3 y) who had acute otalgia and otoscopic evidence of acute inflammation of the ear drum. Exclusion criteria were otoscopic appearances consistent with crying or fever alone (pink ear drum only), appearances more suggestive of OM with effusion and chronic suppurative OM, serious chronic disease, use of antibiotics for ear infections in the previous 2 weeks, previous complications, or if the child was too unwell to be left to wait and see. 285 children (90%) were included in the analysis.InterventionAll patients were prescribed amoxicillin syrup, 125 mg in 5 ml, 3 times daily, 100 ml in total, except for patients allergic to penicillin who were prescribed erythromycin, 125 mg in 5 ml, 4 times daily for 1 week. 164 children were allocated to delayed prescription of antibiotics. Their parents were asked to wait for 72 hours before considering using their prescription. If, after that time, their child still had substantial otalgia or fever or was not getting better, parents were instructed to then pick up the prescription from the office. Parents could, however, pick up the prescription before 72 hours. 151 children were allocated to immediate prescription of antibiotics.Main outcome measuresMain outcome was duration of symptoms (earache, ear discharge, night disturbance, and crying). Other outcomes included number of missed school days, daily episodes of distress, daily consumption of paracetamol (acetaminophen), daily pain scores, number of children who actually took antibiotics, and adverse effects. Data were obtained from daily diaries kept by parents.Main resultsAnalysis was by intention to treat. Children allocated to delayed antibiotics had more days of earache (mean difference [MD] 1.10 d, 95% CI 0.54 to 1.48), ear discharge (MD 0.66 d, CI 0.19 to 1.13), night disturbance (MD 0.72 d, 0.30 to 1.13), and crying (MD 0.69 d, CI 0.31 to 1.08), and higher daily paracetamol consumption (MD 0.52 spoonfuls, CI 0.26 to 0.79) than children allocated to immediate antibiotics. The groups did not differ for number of school days missed, daily episodes of distress, and daily pain scores. Fewer children allocated to delayed prescription actually took the antibiotics compared with children allocated to immediate prescription (table). Fewer children allocated to delayed prescription had diarrhoea (9% v 19%, p=0.02)