BMJ 2002;325:22 ( 6 July )

Primary care

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

Paul Little, clinician scientist, ^a Clare Gould, research assistant, ^a Michael Moore, general practitioner, ^b Greg Warner, general practitioner, ^c Joan Dunleavey, research coordinator, ^a Ian Williamson, senior lecturer. ^a

^a Community Clinical Sciences (Primary Medical Care Group), University of Southampton, Aldermoor Health Centre, Southampton SO15 6ST, ^b Three Swans Surgery, Salisbury, Wiltshire SP1 1DX, ^c Nightingale Surgery, Romsey, Hampshire SO51 7QN

Correspondence to: P Little psl3{at}soton.ac.uk

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, ²=4.0; P=0.045, number needed to treat 5) as was night disturbance (26% v 59%, ²=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%, ²=0.74; P=0.39) or night disturbance (20% v 27%, ²=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.

What is already known on this topic Most children with otitis media will not benefit symptomatically from immediate use of antibiotics It is unclear which children are more likely to benefit from antibiotics and which features predict poor outcome What this study adds Children with high temperature or vomiting were more likely to be distressed or have night disturbance three days after seeing the doctor Children with high temperature or vomiting were more likely to benefit from antibiotics, although it is still reasonable to wait 24-48 hours as many children will settle anyway Children without high temperature or vomiting were unlikely to have poor outcome and unlikely to benefit from immediate antibiotics

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© BMJ 2002
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