NCT00761085CompletedNot Applicable
Methadone in Pediatric and Adult Sickle Cell Patients
Washington University School of Medicine1 site in 1 country47 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
Study Overview
Brief Summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Methadone-Children
Active Comparator
Methadone comparison to standard of care for pain management
Intervention: Methadone (Drug)
Morphine-Children
Active Comparator
Morphine standard of Care pain management
Intervention: Morphine (Drug)
Methadone-Adults
Active Comparator
Methadone comparison to standard of care for pain management
Intervention: Methadone (Drug)
Morphine-Adults
Active Comparator
Morphine standard of Care pain management
Intervention: Morphine (Drug)
Outcomes
Primary Outcomes
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
Time Frame: 96 hr
R-Methadone AUC
Secondary Outcomes
- Pain Relief(72 hr)
Investigators
Study Sites (1)
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