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Analgesic Ear Drops for Children With Acute Otitis Media

NCT05651633 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-05-13

No results posted yet for this study

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

DRUG

lidocaine hydrochloride 5mg/g

1-2 drops up to six times daily for a maximum of 7 days

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Roderick Venekamp · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2023-12-16
Completion
2024-01-10

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651633 on ClinicalTrials.gov