Analgesic Ear Drops for Children With Acute Otitis Media

NCT05651633 | Terminated Phase 3

• 4 other identifiers: 80-87200-98-1017NL9500100600119100032021-003019-24
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The parent-reported ear pain score over the first three days

  Parents will record their child's ear pain scores during the first three consecutive days using a 0-10 validated numerical rating scale. Higher scores indicate greater severity.

  3 days

Secondary Outcomes (11)

• proportion of children consuming antibiotics

  in the first 7 days

• proportion of children with oral analgesic use

  in the first 7 days

• overall symptom burden (crying/distress, disturbed sleep, interference with normal activity, appetite, fever and hearing problems) using a 0-6 Likert scale

  in the first 7 days

• number of days with ear pain

  during follow up (4 weeks)

• number of GP reconsultations with/without subsequent antibiotic prescribing

  during follow-up (4 weeks)

Study Arms (2)

Lidocaine ear drops with usual care

EXPERIMENTAL

usual care: oral analgesic with/without antibiotics

Drug: lidocaine hydrochloride 5mg/g

usual care

NO INTERVENTION

usual care: oral analgesic with/without antibiotics

Interventions

lidocaine hydrochloride 5mg/g DRUG

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

Also known as: Otalgan

Lidocaine ear drops with usual care

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1 to 6 years
• Parent-reported ear pain in 24 hours prior to enrolment
• GP-diagnosis of (uni- or bilateral) AOM

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• de Sevaux JLH, Damoiseaux RAMJ, Hullegie S, Sanders EAM, de Wit GA, Zuithoff NPA, Yardley L, Anthierens S, Little P, Hay AD, Schilder AGM, Venekamp RP. Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: study protocol of the OPTIMA pragmatic randomised controlled trial. BMJ Open. 2023 Feb 22;13(2):e062071. doi: 10.1136/bmjopen-2022-062071.

  PMID: 36813504 DERIVED

MeSH Terms

Conditions

Otitis Media; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Roderick Venekamp

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: pragmatic, two arm, individually randomised, open, superiority trial

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 15, 2022
• Study Start: October 6, 2021
• Primary Completion: December 16, 2023
• Study Completion: January 10, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)