Treatment of Acute Otitis

Media in Children
under 2 Years of Age
Perceptor:
dr. Manan Affandi, Sp.A
dr. Rachmat Gumelar, Sp.A
Feby Wulansari
110.2007.116

ABSTRACT
BACKGROUND
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 PRIMARY outcome measures
were the time to resolution of
symptoms and the symptom burden
over time.

The SECONDARY outcomes :

clinical efficacy, the use of
acetaminophen, the occurrence of
adverse events, nasopharyngeal
colonization rates, and the use of
health care resources.

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.

RESULTS

DISCUSSION