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Could methadone ease agonizing mouth pain in kids after transplant?

NCT ID NCT06940570

What the study statuses mean

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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 This study
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding methadone to usual morphine-based pain medicine reduces severe mouth pain in children aged 6–18 who are getting a stem cell transplant for leukemia, aplastic anemia, or similar conditions. The mouth pain is a common side effect of the chemotherapy given before transplant. Researchers hope the combination will lower pain scores and reduce the total amount of opioids needed. The trial is small (60 participants) and currently on hold.

What this could mean

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

Active substance
methadone
What this could lead to
If it works, this could point toward a better way to manage severe mouth pain in children during stem cell transplant recovery.
What could go wrong
The trial is small (60 participants) and currently suspended, so results may not be conclusive. Methadone also has side effects like drowsiness and breathing problems.

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 60 people

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

Expected to start

Jan 2028

An estimate. Start dates often move.

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

6 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: * All subjects admitted will receive a myeloablative conditioning regimen followed by autologous or allogeneic bone marrow transplant during transplant admission. Conditioning may include chemotherapy, radiation, or a combination of both methods to be determined by primary attending transplant physician. Diagnoses will include but not limited to those with liquid tumors, solid tumors, hematological/congenital blood disorders, or severe combined immunodeficiency syndromes. * Subjects must be 6-18 years of age and demonstrate understanding of PCA use or have a parent available for PCA by proxy, meaning parent can push the button for the patient. Patient maximum age is 18 years old. PCA proxy in compliance with Pain Assessment and Management policy per institution. * Performance status: Karnofsky/Lansky \>50% prior to receiving conditioning. * Be cognitively able to utilize and understand patient-controlled analgesia (PCA). * Informed consent will be obtained from all participants or their parents or guardians, assent will be obtained from children ages 10-17 years of age per institutional policy. Exclusion Criteria: * QT prolongation prior to receiving myeloablative conditioning as evidenced by QTc being \>450 for both girls and boys prior to starting methadone. * Medical history of QT prolongation, VF, or VT. * Patients on chronic pain medications on admission or have received more than 30 days of continuous opioids over the past month. * Patients receiving a non-myeloablative regimen or no conditioning. * Neurological or psychiatric condition that could confound reliable assessment of pain and sedation (non-verbal, global delay). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to morphine or other agents used in study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. * History of opioid misuse disorder OR opioid risk assessment tool score \>8.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Children's Health of Dallas

    Dallas, Texas, 75235, United States

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