Methadone in Pediatric and Adult Sickle Cell Patients
Information source: Washington University School of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Disease
Intervention: Morphine (Drug); Methadone (Drug); Methadone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Evan D Kharasch, MD, PhD, Principal Investigator, Affiliation: Washington University School of Medicine
Summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are
experiencing a painful episode.
Clinical Details
Official title: Methadone in Pediatric and Adult Sickle Cell Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: To determine the pharmacokinetics of methadone in children and adults with Sickle Cell disease experiencing a VOE.
Secondary outcome: Pain
Eligibility
Minimum age: 7 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Barnes Jewish Hospital/St. Louis Children's Hospital, St. Louis, Missouri 63110, United States; Recruiting
Evan D Kharasch, MD, PhD, Phone: 314-362-7551, Email: kharasch@wustl.edu
Patty m Suntrup, BA, CCRP, Phone: 314-747-1709, Email: suntrupp@wust.edu
Evan D Kharasch, MD, PhD, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: November 2009
Last updated: September 11, 2009
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