Status:
COMPLETED
Methadone in Pediatric and Adult Sickle Cell Patients
Lead Sponsor:
Washington University School of Medicine
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
7-40 years
Phase:
NA
Brief Summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00761085
Start Date
January 1 2008
End Date
November 7 2010
Last Update
January 22 2020
Active Locations (1)
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1
Barnes Jewish Hospital/St. Louis Children's Hospital
St Louis, Missouri, United States, 63110