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Numbing ear drops could ease children's ear infection pain faster

NCT ID NCT05651633

Symptom relief Sponsor: UMC Utrecht Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial tests whether adding lidocaine ear drops to standard painkillers provides better ear pain relief for children aged 1–6 with acute otitis media. Half the children receive the ear drops plus usual care (oral painkillers, with or without antibiotics), while the other half receive usual care alone. Parents track their child's pain over three days to see if the drops make a meaningful difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lidocaine hydrochloride ear drops (Otalgan)
What this could lead to
If effective, adding lidocaine ear drops to standard painkillers could offer faster, more complete ear pain relief for children with ear infections, reducing distress and antibiotic use.
What could go wrong
This is a small trial (29 children) and the benefit over usual care may be modest or not statistically significant. Ear drops cannot be used if the eardrum is perforated, and side effects like local irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

29 people

The number who actually took part.

Started

Oct 2021

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infectious otitis media otitis media Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute otitis media Pain

Contacts and locations

Locations

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3584 CX, Netherlands

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