Is treatment with eardrops as good as oral treatment for children with acute otitis media presenting with ear discharge?
Phase 4
Completed
- Conditions
- <p>Acute Otitis media with ear discharge<br />Otitis media acuta met een loopoor</p>10004018
- Registration Number
- NL-OMON23467
- Lead Sponsor
- Sponsor: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
Inclusion Criteria
Children aged 6 months to 12 years whose parents are consulting the GP with AOM and ear discharge in one or both ears (< 7 days duration) and either parent-reported ear pain in the previous 24 hours or fever (child’s body temperature of > 38.0°C in the previous 24 hours as reported by parents or as measured by the GP during consultation) or both.
Exclusion Criteria
Children will be excluded from participation if they;
1. are systemically very unwell and requires immediate oral antibiotics or immediate hospitalisation (e.g. child has signs and symptoms of serious illness and/or complications such as mastoiditis/meningitis);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of children without ear pain (ear pain score 0 on the 0-6 Likert scale) and fever (body temperature below 38.0°C) at day 3.</p><br>
- Secondary Outcome Measures
Name Time Method