NCT05651633

Analgesic Ear Drops for Children With Acute Otitis Media

Effectiveness of Analgesic Ear Drops as add-on Treatment to Oral Analgesics in Children With Acute Otitis Media: a Pragmatic Randomised Controlled Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Media
• Pain

Interventions

Type	Name	Description
DRUG	lidocaine hydrochloride 5mg/g	1-2 drops up to six times daily for a maximum of 7 days

Timeline

• Start date: 2021-10-06
• Primary completion: 2023-12-16
• Completion: 2024-01-10
• First posted: 2022-12-15
• Last updated: 2024-05-13

Locations

1 site across 1 country: Netherlands