Collections under
which this article appears: Children
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, aClare Gould, research assistant, aMichael Moore, general practitioner, bGreg Warner, general practitioner, cJoan Dunleavey, research coordinator, aIan 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
Objectives: To identify which children with acute otitis
media are at risk of poor outcome and to assess benefit from antibioticsin thesechildren. Design: Secondary analysis of randomised controlledtrialcohort. Setting: Primarycare. Participants: 315 children aged 6 months to 10years. Intervention: Immediate or delayed (taken after 72 hoursif
necessary)antibiotics. Main outcome measure: Predictors of short term outcome: an episodeof 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 morelikely with
high temperature 2.4 (1.2 to 4.8), vomiting (2.1,1.1to 4.0), cough
(2.3,1.3 to 4.2), and ear discharge (2.1, 1.2 to3.9). Among the
children with high temperature or vomiting, distressby day three was
less likely with immediate antibiotics (32% forimmediate 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 withouthigher temperature or
vomiting, immediate antibiotics made littledifference 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 improveprediction of
benefit. Conclusion: In children with otitis media but withoutfever
and vomiting antibiotic treatment has little benefit anda poor
outcome isunlikely.
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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