Methadone in Pediatric and Adult Sickle Cell Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-01

Study Completion Date

2010-11-07

Brief Summary

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

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Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methadone-Children

Methadone comparison to standard of care for pain management

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

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

Morphine-Children

Morphine standard of Care pain management

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Standard of care for pain management of acute episode of pain

Methadone-Adults

Methadone comparison to standard of care for pain management

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

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

Morphine-Adults

Morphine standard of Care pain management

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Standard of care for pain management of acute episode of pain

Interventions

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Morphine

Standard of care for pain management of acute episode of pain

Intervention Type DRUG

Methadone

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No