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Could a simple nerve block replace opioids for Children's ear surgery pain?

NCT ID NCT07276906

Symptom relief Sponsor: University of South Alabama 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a nerve block (injecting numbing medicine near the ear) to standard painkillers (fentanyl and ketorolac) for children aged 6 months to 6 years having ear tube surgery. The goal is to see if the nerve block works just as well for pain control, with fewer side effects like nausea or breathing trouble. Three hundred children will be randomly assigned to one of the two approaches, and both families and doctors won't know which treatment was given.

What this could mean

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

Active substance
bupivacaine (nerve block) vs. fentanyl and ketorolac (standard care)
What this could lead to
If it works, this could offer a safer, opioid-free way to manage pain after ear tube surgery in children, reducing risks like nausea and breathing problems.
What could go wrong
This is a single-center trial with 300 children, so results may not apply broadly. The nerve block might not control pain as well as standard drugs, and there is a small risk of side effects from the local anesthetic.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

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

6 months 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 6 months to 6 years Scheduled bilateral myringotomy with tube placement ASA physical status I-II Parent/guardian consent Exclusion Criteria: * Allergy to study medications (fentanyl, ketorolac, bupivacaine) Renal impairment or contraindication to ketorolac Bleeding disorder or anticoagulation Significant obstructive sleep apnea (AHI \>10) Concurrent surgical procedures beyond BMT Unilateral procedure only Recent analgesic use (\<24 hours)

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Conditions

The condition(s) this trial relates to.

otitis media Pain, Postoperative

As listed by the trial registrant

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

Postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children and Woman's Hospital

    Mobile, Alabama, 36604, United States

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