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Could one dose of methadone spare kids from extra pain meds after tonsil surgery?

NCT ID NCT06576830

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a single dose of methadone (a long-acting opioid) given during surgery to standard short-acting opioids for pain relief after tonsillectomy in children ages 3 to 17. The goal is to see if methadone reduces the need for extra pain medication in the recovery room. About 440 children will take part, and the study is double-blind, meaning neither the patients nor the doctors know which treatment is given.

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 440 people

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

Started

Nov 2024

Expected to finish

Jun 2029

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

3 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age \>= 3 and \< 18 years 2. Elective tonsillectomy +/- adenoidectomy 3. Signed informed consent by parent or legal guardian 4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent 5. Negative pregnancy test within 48 hours for post pubescent females Exclusion Criteria: 1. History of chronic kidney or liver disease 2. Current diagnosis of a chronic pain disorder 3. Planned admission to the Pediatric Intensive Care Unit (PICU) 4. Additional procedures under general anesthesia for which opioids would be prescribed

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative sleep apnea syndrome tonsillitis

As listed by the trial registrant

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

Pain, postoperative Pediatric sleep apnea Sleep-disordered breathing Tonsillar hypertrophy Tonsillitis

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

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.