Methadone as an Alternative Treatment for Children Underdoing HSCT

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding methadone, a type of pain medication, can help reduce pain in children aged 6 to 18 who are undergoing stem cell transplants for conditions like leukemia and other serious blood disorders. When children receive a stem cell transplant, they often experience painful mouth sores due to the chemotherapy used before the transplant. Currently, morphine is given to manage this pain, but it doesn’t always work well enough. The hope is that using methadone alongside morphine may provide better pain relief while waiting for the new donor cells to heal their mouths.

To be eligible for this study, children must be between 6 and 18 years old and require a stem cell transplant after receiving chemotherapy or radiation. They should also be able to understand how to use a patient-controlled pain management system or have a parent who can help. Participants will receive both morphine and methadone during their hospital stay at Children's Medical Center of Dallas, and there’s no cost for the medication. The trial aims to see if the combination of these medications improves pain management, helps children eat sooner, and reduces their hospital stay, while also monitoring for any side effects.

Gender

ALL

Eligibility criteria

• 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.