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Methadone in Pediatric and Adult Sickle Cell Patients

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Jane Blood, RN, Phone: 314-747-5531, Email: bloodj@wust.edu
Evan D Kharasch, MD, PhD, Principal Investigator
Additional Information

Starting date: January 2008
Last updated: August 13, 2015

Page last updated: August 23, 2015

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