Could methadone ease agonizing mouth pain in kids after transplant?
NCT ID NCT06940570
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2028
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Children's Health of Dallas
Dallas, Texas, 75235, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as a cure for severe aplastic anemia
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- Two-Drug combo aims to push CLL into deep remission
- Can a pill revive bone marrow in aplastic anemia?
- Ultrasound may reveal hidden bone damage in blood cancers
- Can a Tumor's DNA guide better cancer care for kids?