Single-dose intramuscular ceftriaxone for acute otitis media in children

Abstract

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.