analgesic ear drops for children with acute otitis media

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Age 1 to 6 years
- GP-diagnosis of (uni- or bilateral) AOM
- Parent-reported ear pain in 24 hours prior to enrolment

Exclusion Criteria

- Children with (suspected) non-intact tympanic membrane (perforation or tubes) with/without otorrhoea, including children with ear wax which hampers accurate tympanic membrane assessment upon otoscopy.
- Children 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).
- Children who are at high risk of serious complications including children with known immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial malformation such as cleft palate, Down syndrome and previous ear surgery
- Children who have a known allergy or sensitivity to study medicine or similar substances, e.g. other amide-type anesthetics (such as bupivacaine, mepivacaine and prilocaine)
- Children 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.
- Children who need to continue taking other medicinal products containing lidocaine
- Children who have proven alternative source(s) of pain other than, and more severe than, the ear symptoms with which they are presenting.
- Children who have already participated in this trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the mean parent-reported ear pain score (using a 0-10 validated numerical rating scale) over the first three days.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include proportion of children consuming antibiotic in the first 7 days, number of days with ear pain during follow-up (4 weeks), overall symptom burden in the first 7 days, oral and topical analgesic use in the first 7 days, number of GP reconsultations with/without subsequent antibiotic prescribing during follow-up, generic and disease-specific quality of life at the end of follow-up, adverse events during follow-up, complications of AOM during follow-up, cost-effectiveness, and parents’ and GPs’ views of treatment acceptability, usability and satisfaction (qualitative investigation).