Sickle Cell Disease
Conditions
Brief summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
Interventions
DRUGMorphine
Standard of care for pain management of acute episode of pain
DRUGMethadone
Compare to standard of care for pain management of acute episode of pain
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | 96 hr | R-Methadone AUC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methadone-Children Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain | 12 |
| Morphine-Children Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain | 12 |
| Methadone-Adults Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain | 11 |
| Morphine-Adults Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain | 12 |
| Total | 47 |
Baseline characteristics
| Characteristic | Morphine-Children | Methadone-Adults | Morphine-Adults | Total | Methadone-Children |
|---|---|---|---|---|---|
| Age, Continuous | 14 years STANDARD_DEVIATION 3 | 25 years STANDARD_DEVIATION 6 | 25 years STANDARD_DEVIATION 7 | 22 years STANDARD_DEVIATION 5 | 15 years STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 12 participants | 11 participants | 12 participants | 47 participants | 12 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 7 Participants | 23 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 5 Participants | 24 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 12 |
Outcome results
Primary
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
R-Methadone AUC
Time frame: 96 hr
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methadone-Children | To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | 523 (hr*ng/ml) | Standard Deviation 248 |
| Morphine-Children | To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | 0 (hr*ng/ml) | Standard Deviation 0 |
| Methadone-Adults | To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | 637 (hr*ng/ml) | Standard Deviation 324 |
| Morphine-Adults | To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | 0 (hr*ng/ml) | Standard Deviation 0 |
Comparison: No statistical comparisons of methadone concentration in patients receiving methadone vs not receiving methadone (children or adults).~No statistical comparisons of methadone concentration in children vs adults
Secondary
Pain Relief
Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced
Time frame: 72 hr
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methadone-Children | Pain Relief | 8 units on a scale | Standard Deviation 2 |
| Morphine-Children | Pain Relief | 4 units on a scale | Standard Deviation 3 |
| Methadone-Adults | Pain Relief | 5 units on a scale | Standard Deviation 3 |
| Morphine-Adults | Pain Relief | 5 units on a scale | Standard Deviation 2 |
p-value: <0.05ANOVA