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Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial
David M Spiro1, Khoon-Yen Tay, Donald H Arnold
1Department of Pediatrics, Yale University School of Medicine, New Haven, Conn, USA. spirod@ohsu.edu
Insights
A wait-and-see prescription (WASP) for acute otitis media (AOM) in children significantly reduced antibiotic use in emergency departments. This approach did not worsen clinical symptoms or increase unscheduled medical visits.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Trials
Background:
- Acute otitis media (AOM) is a leading cause of pediatric antibiotic prescriptions.
- Previous "wait-and-see prescription" (WASP) trials excluded severe AOM cases and were not conducted in emergency departments.
- The study addresses the need for evidence on WASP in emergency department settings for AOM.
Purpose of the Study:
- To evaluate the efficacy of a WASP strategy in reducing antibiotic use for pediatric AOM.
- To compare the clinical outcomes and adverse effects of WASP versus standard antibiotic prescriptions (SP).
- To assess the impact of WASP on symptom resolution and healthcare utilization in children with AOM.
Main Methods:
- A randomized controlled trial involving children aged 6 months to 12 years with AOM in an emergency department.
- Participants were randomized to receive either a WASP or an SP for antibiotics.
- Outcomes were assessed via structured phone interviews by a blinded research assistant.
Main Results:
- A significantly higher proportion of parents in the WASP group (62%) did not fill the antibiotic prescription compared to the SP group (13%).
- No significant differences were observed in subsequent fever, ear pain (otalgia), or unscheduled medical visits between the groups.
- Within the WASP group, filling the prescription was associated with increased fever and otalgia.
Conclusions:
- The WASP approach substantially decreases unnecessary antibiotic prescriptions for pediatric AOM in emergency departments.
- WASP represents a viable alternative to routine antibiotic treatment for children with AOM.
- This strategy may help mitigate antibiotic resistance by reducing overall antibiotic consumption.
Context:
Acute otitis media (AOM) is the most common diagnosis for which antibiotics are prescribed for children. Previous trials that have evaluated a "wait-and-see prescription" (WASP) for antibiotics, with which parents are asked not to fill the prescription unless the child either is not better or is worse in 48 hours, have excluded children with severe AOM. None of these trials were conducted in an emergency department.
Objectives:
To determine whether treatment of AOM using a WASP significantly reduces use of antibiotics compared with a "standard prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.
Design, Setting, And Patients:
A randomized controlled trial conducted between July 12, 2004, and July 11, 2005. Children with AOM aged 6 months to 12 years seen in an emergency department were randomly assigned to receive either a WASP or an SP. All patients received ibuprofen and otic analgesic drops for use at home. A research assistant, blinded to group assignment, conducted structured phone interviews 4 to 6, 11 to 14, and 30 to 40 days after enrollment to determine outcomes.
Main Outcome Measures:
Filling of the antibiotic prescription and clinical course.
Results:
Overall, 283 patients were randomized either to the WASP group (n = 138) or the SP group (n = 145). Substantially more parents in the WASP group did not fill the antibiotic prescription (62% vs 13%; P<.001). There was no statistically significant difference between the groups in the frequency of subsequent fever, otalgia, or unscheduled visits for medical care. Within the WASP group, both fever (relative risk [RR], 2.95; 95% confidence interval [CI], 1.75 - 4.99; P<.001) and otalgia (RR, 1.62; 95% CI, 1.26 - 2.03; P<.001) were associated with filling the prescription.
Conclusion:
The WASP approach substantially reduced unnecessary use of antibiotics in children with AOM seen in an emergency department and may be an alternative to routine use of antimicrobials for treatment of such children.
Trial Registration:
clinicaltrials.gov Identifier: NCT00250900.
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