Recommendations vary regarding immediate antimicrobial treatment
versus watchful waiting for children younger than 2 years of age
with acute otitis media.
METHODS
We randomly assigned 291 children 6 to 23 months of age, with
acute otitis media diagnosed with the use of stringent criteria, to
receive amoxicillinclavulanate or placebo for 10 days.
RANDOMIZATION
they had a history of recurrent acute otitis media according to
their exposure or nonexposure to three or more children for at
least 10 hours per week
ASSESSMENT OF SYMPTOMS
OTOSCOPIC EXAMINATION, OVERALL ASSESSMENT, AND MANAGEMENT
OUTCOMES
The SECONDARY outcomes : clinical efficacy, the use of
acetaminophen, the occurrence of adverse events, nasopharyngeal
colonization rates, and the use of health care resources.The
PRIMARY outcome measures were the time to resolution of symptoms
and the symptom burden over time.
STATISTICAL ANALYSIS
With a sample of 120 children, the study would have 80% power to
detect a 66% lower rate of resolution of symptoms in the placebo
group as compared with the amoxicillinclavulanate group.
