Clinical trial NCT05651633: Analgesic Ear Drops for Children With Acute Otitis Media
Official title: Effectiveness of Analgesic Ear Drops as add-on Treatment to Oral Analgesics in Children With Acute Otitis Media: a Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Otitis Media
Pain
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic, two arm, individually randomised, open, superiority trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The parent-reported ear pain score over the first three days
timeFrame: 3 days
Secondary outcomes:
measure: proportion of children consuming antibiotics
timeFrame: in the first 7 days
measure: proportion of children with oral analgesic use
timeFrame: in the first 7 days
measure: overall symptom burden (crying/distress, disturbed sleep, interference with normal activity, appetite, fever and hearing problems) using a 0-6 Likert scale
timeFrame: in the first 7 days
measure: number of days with ear pain
timeFrame: during follow up (4 weeks)
measure: number of GP reconsultations with/without subsequent antibiotic prescribing
timeFrame: during follow-up (4 weeks)
measure: number of participants with adverse events
timeFrame: during follow-up (4 weeks)
measure: number of participants with complications of AOM
timeFrame: during follow-up (4 weeks)
measure: costs
timeFrame: during follow-up (4 weeks)
measure: generic quality of life of the child assessed using the 47-item short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)
timeFrame: at baseline and at 4 weeks
measure: disease-specific quality of life of the child assessed using the Otitis media-6 (OM-6) questionnaire
timeFrame: at baseline and at 4 weeks
measure: incremental cost-effectiveness ratios; calculated by dividing the estimated differences in costs between groups by the differences in effects observed
timeFrame: during follow-up (4 weeks)
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Roderick Venekamp
role: PRINCIPAL_INVESTIGATOR
References: