Methadone in Pediatric and Adult Sickle Cell Patients - Full Text View

Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

This study is currently recruiting participants.

Verified July 2011 by Washington University School of Medicine

First Received on September 24, 2008. Last Updated on July 28, 2011 History of Changes

Sponsor:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00761085

Purpose

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

Condition	Intervention
Sickle Cell Disease	Drug: Morphine Drug: Methadone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Methadone in Pediatric and Adult Sickle Cell Patients

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Sickle Cell Anemia

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

To determine the pharmacokinetics of methadone in children and adults with Sickle Cell disease experiencing a VOE. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain [ Time Frame: November 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Comparison to standard of care for pain management	Drug: Methadone Methadone given to compare to standard of care for pain management Drug: Methadone Patients are randomized to either receive standard of care or methadone for pain management of acute episode of pain.
Active Comparator: 2 Standard of Care pain management	Drug: Morphine Standard of care for pain management of acute episode of pain

Eligibility

Ages Eligible for Study:	7 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761085

Locations

United States, Missouri
Barnes Jewish Hospital/St. Louis Children's Hospital	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Evan D Kharasch, MD, PhD 314-362-7551 kharasch@wustl.edu
Contact: Jane Blood, RN 314-747-5531 bloodj@wust.edu
Principal Investigator: Evan D Kharasch, MD, PhD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Evan D Kharasch, MD, PhD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Evan Kharasch, MD, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00761085 History of Changes
Other Study ID Numbers:	07-0938
Study First Received:	September 24, 2008
Last Updated:	July 28, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Methadone
Morphine
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012