Analgesic Ear Drops for Children With Acute Otitis Media
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
This trial aims to investigate whether analgesic ear drops added to usual care provide
superior ear pain relief over usual care alone in children presenting to primary care with
AOM. Children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride
5mg/g ear drops (Otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition
to usual care (oral analgesics, with/without antibiotics) or 2) usual care. Parents will
complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life
questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain
score (0-10) over the first 3 days.
NOTE:
At the time of publication of the study protocol paper, the investigators were unable to make
any amendments to the trial registration record in the Netherlands Trial Register (NTR)
(NL9500; date of registration: 28 May 2021). The addition of a data sharing plan was required
to adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. The
investigators therefore re-registered the trial in ClinicalTrials.gov. This second
registration is for modification purposes only and the NTR record (NL9500) should be regarded
as the primary trial registration.