NL-OMON54000
Completed
Phase 3
Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: a pragmatic randomised controlled trial - analgesic ear drops for children with acute otitis media (OPTIMA)
niversitair Medisch Centrum Utrecht0 sites300 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age 1 to 6 years
- •\- Parent\-reported ear pain in 24 hours prior to enrolment
- •\- GP\-diagnosis of (uni\- or bilateral) AOM
Exclusion Criteria
- •\- with (suspected) tympanic membrane perforation or ventilation tubes
- •\- with ear wax obscuring visualisation of the tympanic membrane
- •\- who are systemically very unwell or require hospital admission (e.g. child
- •has signs and symptoms of serious illness and/or complications such as
- •mastoiditis/meningitis).
- •\- who are at high risk of serious complications including children with known
- •immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial
- •malformation including cleft palate, Down syndrome and previous ear surgery
- •(with the exception of ventilation tubes in the past).
- •\- who have a known allergy or sensitivity to study medication or similar
Outcomes
Primary Outcomes
Not specified
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