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New methadone protocol aims to ease pain and cut opioid use in kids after heart surgery

NCT ID NCT06626035

Symptom relief Sponsor: Senthil Sadhasivam 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 1 time

Summary

This study tests a methadone-based recovery plan to improve pain control and reduce opioid use in children after heart surgery. About 500 children aged 3 to 18 will be randomly assigned to either the new methadone plan or standard care. The goal is to see if the new approach lowers pain scores and the amount of opioids needed.

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

About 500 people

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

Started

Dec 2025

Expected to finish

Aug 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 18 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: * Children aged 3-years - \<18 years * ASA physical status 1, 2, or 3 * Participant or legal guardian can speak and read English or Spanish * Undergoing the following cardiac surgeries (Categories 1 \& 2) that are associated with significant acute surgical pain STS Category 1: * ASD, PFO closure * VSD repairs, * Aortic stenosis sub-valvular repair * ASD and Partial anomalous venous return repair * AV canal transitional * Conduit replacement * Valve replacement (AVR, PVR) * TOF repair without ventriculostomy STS Category 2: * Glenn shunt (on Bypass only) * Fontan surgery (on Bypass only) * Pulmonary artery plasty (main) * Left Atrium (LA) to Pulmonary Artery (PA) conduit replacement. Exclusion Criteria: * Pregnant patients * Methadone allergy * Preoperative prolonged QTc more than 460 msec (-30 days to 0 day) * Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine) * Preoperative opioid use within 30 days before surgery * History of severe sleep apnea (have a sleep study with an AHI index score more than 10 or clinical signs of sleep disordered breathing - snoring, daytime drowsiness) * Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Pediatric cardiac surgery

How to take part

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

  1. The places running it

    3 sites. 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

  • Cincinnati Children's Hospital Medical Center

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • UCSF Benioff Children's Hospital

    NOT_YET_RECRUITING

    Oakland, California, 94618, United States

  • UPMC Children's Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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