Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

The Washington University

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Drug: Methadone; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00761085

201107091

Details and patient eligibility

About

To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.

Enrollment: 47 patients

Sex: All

Ages: 7 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 7 years and less than or equal to 40 years
• Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
• Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
• Admitted to the inpatient unit for further treatment
• Started on morphine patient controlled analgesia and infusion for pain management

Exclusion criteria

• Diagnosis of acute chest syndrome
• New focal neurologic findings or clinical concern of stroke
• Aplastic crisis with hemoglobin 2 g/dl below steady-state value
• Allergy to morphine or methadone
• Any other medical condition that the attending physician deems to be a contraindication to therapy
• Liver or renal insufficiency or failure, and congestive heart failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 4 patient groups

Methadone-Children

Active Comparator group

Description:

Methadone comparison to standard of care for pain management

Treatment:

Drug: Methadone

Morphine-Children

Active Comparator group

Description:

Morphine standard of Care pain management

Treatment:

Drug: Morphine

Methadone-Adults

Active Comparator group

Description:

Methadone comparison to standard of care for pain management

Treatment:

Drug: Methadone

Morphine-Adults

Active Comparator group

Description:

Morphine standard of Care pain management

Treatment:

Drug: Morphine