The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Placebo mixture in two daily doses for 7 days
Department of Pediatrics, Oulu University Hospital
Oulu, Finland
Lääkärikeskus Mehiläinen
Oulu, Finland
Time (days) to disappearance of middle ear effusion
Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.
Time frame: Within 60 days
Time (days) to disappearance of pain
Time frame: Within 60 days
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