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Clinical Trial
. 2001 Feb 10;322(7282):336-42.
doi: 10.1136/bmj.322.7282.336.

Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media

Affiliations
Clinical Trial

Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media

P Little et al. BMJ. .

Abstract

Objective: To compare immediate with delayed prescribing of antibiotics for acute otitis media.

Design: Open randomised controlled trial.

Setting: General practices in south west England.

Participants: 315 children aged between 6 months and 10 years presenting with acute otitis media.

Interventions: Two treatment strategies, supported by standardised advice sheets-immediate antibiotics or delayed antibiotics (antibiotic prescription to be collected at parents' discretion after 72 hours if child still not improving).

Main outcome measures: Symptom resolution, absence from school or nursery, paracetamol consumption.

Results: On average, symptoms resolved after 3 days. Children prescribed antibiotics immediately had shorter illness (-1.1 days (95% confidence interval -0.54 to -1.48)), fewer nights disturbed (-0.72 (-0.30 to -1.13)), and slightly less paracetamol consumption (-0.52 spoons/day (-0.26 to -0.79)). There was no difference in school absence or pain or distress scores since benefits of antibiotics occurred mainly after the first 24 hours-when distress was less severe. Parents of 36/150 of the children given delayed prescriptions used antibiotics, and 77% were very satisfied. Fewer children in the delayed group had diarrhoea (14/150 (9%) v 25/135 (19%), chi(2)=5.2, P=0.02). Fewer parents in the delayed group believed in the effectiveness of antibiotics and in the need to see the doctor with future episodes.

Conclusion: Immediate antibiotic prescription provided symptomatic benefit mainly after first 24 hours, when symptoms were already resolving. For children who are not very unwell systemically, a wait and see approach seems feasible and acceptable to parents and should substantially reduce the use of antibiotics for acute otitis media.

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Figures

Figure 1
Figure 1
Flow of participants through trial
Figure 2
Figure 2
Duration of symptoms of acute otitis media in children after seeing doctor
Figure 3
Figure 3
Mean (SE) daily pain score, distress, and use of analgesia in children with acute otitis media after seeing doctor

References

    1. Bain J. Controversies in therapeutics: Childhood otalgia: justification for antibiotic use in general practice. BMJ. 1990;300:1006–1007. - PMC - PubMed
    1. Browning G. Controversies in therapeutics: childhood otalgia: acute otitis media. Antibiotics not necessary in most cases. BMJ. 1990;300:1005–1006. - PMC - PubMed
    1. Froom J, Culpepper L, Jacobs M. Antimicrobials for acute otitis media? A review from the international primary care network. BMJ. 1997;315:98–102. - PMC - PubMed
    1. Del Mar C, Glaziou P, Hayem M. Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis. BMJ. 1997;314:1526–1529. - PMC - PubMed
    1. Burke P, Bain J, Robinson D, Dunleavey J. Acute red ear in children: controlled trial of non-antibiotic treatment in general practice. BMJ. 1991;303:558–562. - PMC - PubMed

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