Predictors of poor outcome and benefits from antibiotics in children with acute otitis media: pragmatic randomised trial.

OBJECTIVES To identify which children with acute otitis media are at risk of poor outcome and to assess benefit from antibiotics in these children. DESIGN Secondary analysis of randomised controlled trial cohort. SETTING Primary care. PARTICIPANTS 315 children aged 6 months to 10 years. INTERVENTION Immediate or delayed (taken after 72 hours if necessary) antibiotics. MAIN OUTCOME MEASURE Predictors of short term outcome: an episode of distress or night disturbance three days after child saw doctor. RESULTS Distress by day three was more likely in children with high temperature (adjusted odds ratio 4.5, 95% confidence interval 2.3 to 9.0), vomiting (2.6,1.3 to 5.0), and cough (2.0, 1.1 to 3.8) on day one. Night disturbance by day three was more likely with high temperature 2.4 (1.2 to 4.8), vomiting (2.1,1.1 to 4.0), cough (2.3,1.3 to 4.2), and ear discharge (2.1, 1.2 to 3.9). Among the children with high temperature or vomiting, distress by day three was less likely with immediate antibiotics (32% for immediate v 53% for delayed, chi2=4.0; P=0.045, number needed to treat 5) as was night disturbance (26% v 59%, chi2=9.3; P=0.002; number needed to treat 3). In children without higher temperature or vomiting, immediate antibiotics made little difference to distress by day three (15% v 19%, chi2=0.74; P=0.39) or night disturbance (20% v 27%, chi2=1.6; P=0.20). Addition of cough did not significantly improve prediction of benefit. CONCLUSION In children with otitis media but without fever and vomiting antibiotic treatment has little benefit and a poor outcome is unlikely.