Comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old childre
Phase 3
- Conditions
- Otitis media.Other acute nonsuppurative otitis media
- Registration Number
- IRCT20111224008507N2
- Lead Sponsor
- Sari University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Age 6 months to 6 years
Acute otitis media with signs started within 48 hours
Not having severe symptoms and ear otorrhea
Unilateral or bilateral involvement
Exclusion Criteria
Severe otalgia
Fever higher than 39 degrees
Underlying diseases such as immunodeficiency (except asthma and allergy)
Amoxicillin intake in the last 30 days
Concurrent conjunctivitis
Ear otorrhea
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fever. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Thermometer.;Otalgia. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Observation.;Mastoiditis. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination.;Middle ear effusion. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination.
- Secondary Outcome Measures
Name Time Method Frequency of acute otitis media. Timepoint: One and three months after treatment. Method of measurement: Observation.;Middle ear effusion. Timepoint: One and three months after treatment. Method of measurement: Examination.