Analgesic Ear Drops for Children With Acute Otitis Media

Launched by UMC UTRECHT · Dec 6, 2022

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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 substances (e.g. other amide-type anaesthetics: bupivacaine, mepivacaine, prilocaine, etc)
• • who have taken part in any research involving medicines within the last 90 days, or any other AOM-related research within the last 30 days
• • who suffer from chronic recurrent pain of another origin than the ear
• • who have participated in this trial during prior AOM episode

Trial Officials