Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: a pragmatic randomised controlled trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

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

Children:
- 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)
- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the mean parent-reported ear pain score over the first 3<br /><br>days, using a 0-10 validated numerical rating scale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include: proportion of children using antibiotics, oral<br /><br>analgesic use and overall symptom burden in the first 7 days; number of days<br /><br>with ear pain, number of GP reconsultations and subsequent antibiotic<br /><br>prescribing, adverse events, complications of AOM and cost-effectiveness during<br /><br>4-week follow-up; generic and disease-specific quality of life at 4 weeks;<br /><br>parents* and GPs* views on treatment acceptability, usability and satisfaction<br /><br>(nested mixed methods process evaluation).</p><br>