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Completed

NCT Number: NCT00761085

Methadone in Pediatric and Adult Sickle Cell Patients

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

7 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital/St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

Standard of care for pain management of acute episode of pain

Methadone

Drug

Compare to standard of care for pain management of acute episode of pain

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: MSCD

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2008
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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