Analgesic Ear Drops for Children With Acute Otitis Media (OPTIMA)
Acute Otitis Media, Pain
About this trial
This is an interventional treatment trial for Acute Otitis Media
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
Sites / Locations
- University Medical Center UtrechtRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Lidocaine ear drops with usual care
usual care
usual care: oral analgesic with/without antibiotics
usual care: oral analgesic with/without antibiotics