Single-dose intramuscular ceftriaxone for acute otitis media in children

Pediatrics. 1993 Jan;91(1):23-30.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acoustic Impedance Tests
  • Acute Disease
  • Amoxicillin / administration & dosage
  • Amoxicillin / economics
  • Amoxicillin / therapeutic use
  • Ceftriaxone / administration & dosage*
  • Ceftriaxone / economics
  • Ceftriaxone / therapeutic use
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Costs
  • Female
  • Humans
  • Infant
  • Injections, Intramuscular
  • Male
  • Otitis Media / diagnosis
  • Otitis Media / drug therapy*
  • Otitis Media / pathology
  • Prospective Studies
  • Recurrence
  • Treatment Failure
  • Treatment Outcome

Substances

  • Ceftriaxone
  • Amoxicillin