Otitis Media, Suppurative
Conditions
Keywords
middle ear effusion, amoxicillin-clavulanate, tympanometry
Brief summary
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.
Interventions
DRUGPlacebo
Placebo mixture in two daily doses for 7 days
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children with acute otitis media
Exclusion criteria
* Amoxicillin allergy * Tympanic membrane perforation * Tympanostomy tubes (current) * Complication of acute otitis media such as mastoiditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (days) to disappearance of middle ear effusion | Within 60 days | Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry. |
Secondary
| Measure | Time frame |
|---|---|
| Time (days) to disappearance of pain | Within 60 days |
Countries
Finland
Outcome results
None listed