Analgesic Ear Drops for Children With Acute Otitis Media (OPTIMA)

UMC Utrecht

Status and phase

Terminated

Phase 3

Conditions

Acute Otitis Media

Pain

Treatments

Drug: lidocaine hydrochloride 5mg/g

Study type

Interventional

Funder types

Other

Identifiers

NCT05651633

2021-003019-24 (EudraCT Number)

80-87200-98-1017

10060011910003 (Other Grant/Funding Number)

NL9500 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

1 to 6 years old

Volunteers

No Healthy Volunteers

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

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, etc)
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