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Single-dose intramuscular ceftriaxone for acute otitis media in children
1Dept of Emergency Medicine, Riverside General Hospital, CA 92503.
Insights
A single dose of intramuscular ceftriaxone effectively treats acute otitis media in children, matching the efficacy of oral amoxicillin. This study offers a potential single-dose treatment option for this common childhood infection.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Acute otitis media (AOM) is a common childhood infection.
- Current treatments for AOM typically involve multiple-day oral antibiotic courses.
- There is a need for effective single-dose treatment options for AOM.
Purpose of the Study:
- To evaluate the efficacy of a single intramuscular dose of ceftriaxone compared to a 10-day course of oral amoxicillin for treating uncomplicated AOM in children.
- To determine if ceftriaxone offers a viable single-dose alternative to standard amoxicillin treatment.
Main Methods:
- A prospective, randomized, double-blind, clinical trial involving 233 children aged 5 months to 5 years with uncomplicated AOM.
- Participants 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 oral amoxicillin (40 mg/kg/day divided TID) for 10 days.
- Outcomes were assessed based on treatment success rates, clinical improvement, failure, relapse, reinfection, and otoscopic/tympanometric evaluations at 14 and 60 days.
Main Results:
- Treatment success rates were similar in both groups: 91% (107/117) for amoxicillin and 91% (105/116) for ceftriaxone.
- Rates of improvement, failure, relapse, and reinfection were comparable between the ceftriaxone and amoxicillin treatment arms.
- Otoscopic and tympanometric evaluations at follow-up visits showed no significant differences between the groups.
Conclusions:
- A single intramuscular injection of ceftriaxone (50 mg/kg) is as effective as a 10-day course of oral amoxicillin for treating uncomplicated acute otitis media in children.
- Ceftriaxone offers a promising single-dose therapeutic option for pediatric AOM, potentially improving treatment adherence and convenience.
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.