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Sickle Cell Disease | Methadone in Pediatric and Adult Sickle Cell Patients

Sickle Cell Disease research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sickle Cell Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MorphineStandard of care for pain management of acute episode of pain

Drug:MethadoneMethadone given to compare to standard of care for pain management

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MethadoneMethadone comparison to standard of care for pain management

MorphineMophine standard of Care pain management

Study Status

Recruiting

Start Date: January 2008

Completed Date: December 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: To determine the pharmacokinetics of methadone in children and adults with Sickle Cell disease experiencing a VOE.

Secondary Outcome: Pain

Study sponsors, principal investigator, and references

Principal Investigator: Evan D Kharasch, MD, PhD

Lead Sponsor: Washington University School of Medicine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00761085

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