Single-dose intramuscular ceftriaxone for acute otitis media in children.
This study evaluated the efficacy of a single dose of intramuscular ceftriaxone for acute otitis media in children, using amoxicillin as a control. (There is currently no established single-dose treatment for this condition.) In a prospective, randomized, double-blind, clinical trial, 233 children, aged 5 months to 5 years, with uncomplicated acute otitis media were randomly assigned to receive either a single intramuscular injection of ceftriaxone (50 mg/kg) plus placebo oral suspension for 10 days, or a placebo injection plus amoxicillin oral suspension (40 mg/kg per day divided three times per day) for 10 days in a double-blind fashion. Demographic and clinical characteristics were similar in both groups. Treatment was successful in 107 of 117 given amoxicillin (91%, 95% confidence interval 86% to 97%) and 105 of 116 given ceftriaxone (91%, 95% confidence interval 85% to 96%). Rates of improvement, failure, relapse, and reinfection were similar in both groups, as were the otoscopic and tympanometric evaluations at the 14- and 60-day follow-up visits. It is concluded that a single intramuscular injection of ceftriaxone (50 mg/kg) is as effective as 10 days of oral amoxicillin for the treatment of uncomplicated acute otitis media in children.
Green
S M
SM
Dept of Emergency Medicine, Riverside General Hospital, CA 92503.
Rothrock
S G
SG
D000158:Acoustic Impedance Tests; D000208:Acute Disease; D000658:Amoxicillin / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D002443:Ceftriaxone / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D016527:Drug Costs; D005260:Female; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D008297:Male; D010033:Otitis Media / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D012008:Recurrence; D017211:Treatment Failure; D016896:Treatment Outcome
D002443:Ceftriaxone; D000658:Amoxicillin