Methadone in Pediatric and Adult Sickle Cell Patients

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Drug: Methadone; Drug: Morphine

• Registration Number: NCT00761085
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-01
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-26
• Primary Completion: 2010-11-07
• Study Completion: 2010-11-07
• Results First Submitted: 2018-06-18
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Results First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methadone-Children	Methadone	Methadone comparison to standard of care for pain management
Morphine-Adults	Morphine	Morphine standard of Care pain management
Morphine-Children	Morphine	Morphine standard of Care pain management
Methadone-Adults	Methadone	Methadone comparison to standard of care for pain management

Primary Outcome Measures

Name	Time	Method
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.	96 hr	R-Methadone AUC

Secondary Outcome Measures

Name	Time	Method
Pain Relief	72 hr	Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced

Trial Locations

Locations (1)

Barnes Jewish Hospital/St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States