Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT05651633
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
6 Years
Study:
NCT05651633
Study Brief:
Protocol Section:
NCT05651633