Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial.
BACKGROUND
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.


OBJECTIVE
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00250900.
Spiro
David M
DM
Department of Pediatrics, Yale University School of Medicine, New Haven, Conn, USA. spirod@ohsu.edu
Tay
Khoon-Yen
KY
Arnold
Donald H
DH
Dziura
James D
JD
Baker
Mark D
MD
Shapiro
Eugene D
ED
D000208:Acute Disease; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004363:Drug Utilization; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D013997:Time Factors; D019564:Unnecessary Procedures
D018712:Analgesics, Non-Narcotic; D000900:Anti-Bacterial Agents