Methadone in Pediatric and Adult Sickle Cell Patients

Sickle Cell Disease Clinical Trial

— MSCD  

Official title:

Methadone in Pediatric and Adult Sickle Cell Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761085
• Other study ID #: 201107091
• Status: Completed
• Phase: N/A
• Start date: January 1, 2008
• Est. completion date: November 7, 2010

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 7, 2010
• Est. primary completion date: November 7, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Morphine
Standard of care for pain management of acute episode of pain
• Methadone
Compare to standard of care for pain management of acute episode of pain

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital/St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.	R-Methadone AUC	96 hr
Secondary	Pain Relief	Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced	72 hr