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Methadone in Pediatric and Adult Sickle Cell Patients (MSCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00761085
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Morphine Drug: Methadone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methadone in Pediatric and Adult Sickle Cell Patients
Actual Study Start Date : January 1, 2008
Actual Primary Completion Date : November 7, 2010
Actual Study Completion Date : November 7, 2010


Arm Intervention/treatment
Active Comparator: Methadone-Children
Methadone comparison to standard of care for pain management
Drug: Methadone
Compare to standard of care for pain management of acute episode of pain

Active Comparator: Morphine-Children
Morphine standard of Care pain management
Drug: Morphine
Standard of care for pain management of acute episode of pain

Active Comparator: Methadone-Adults
Methadone comparison to standard of care for pain management
Drug: Methadone
Compare to standard of care for pain management of acute episode of pain

Active Comparator: Morphine-Adults
Morphine standard of Care pain management
Drug: Morphine
Standard of care for pain management of acute episode of pain




Primary Outcome Measures :
  1. To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. [ Time Frame: 96 hr ]
    R-Methadone AUC


Secondary Outcome Measures :
  1. Pain Relief [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761085


Locations
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United States, Missouri
Barnes Jewish Hospital/St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Evan D Kharasch, MD, PhD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00761085    
Other Study ID Numbers: 201107091
First Posted: September 26, 2008    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Morphine
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents