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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone-Children | Active Comparator | Methadone comparison to standard of care for pain management |
|
| Morphine-Children | Active Comparator | Morphine standard of Care pain management |
|
| Methadone-Adults | Active Comparator | Methadone comparison to standard of care for pain management |
|
| Morphine-Adults | Active Comparator | Morphine standard of Care pain management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | Standard of care for pain management of acute episode of pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | R-Methadone AUC | 96 hr |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan D Kharasch, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital/St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27572136 | Derived | Horst J, Frei-Jones M, Deych E, Shannon W, Kharasch ED. Pharmacokinetics and analgesic effects of methadone in children and adults with sickle cell disease. Pediatr Blood Cancer. 2016 Dec;63(12):2123-2130. doi: 10.1002/pbc.26207. Epub 2016 Aug 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Morphine-Children | Morphine standard of Care pain management Morphine: Standard of care for pain management of acute episode of pain |
| FG002 | 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 |
| FG003 | Morphine-Adults | Morphine standard of Care pain management Morphine: Standard of care for pain management of acute episode of pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Morphine-Children |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | R-Methadone AUC | Posted | Mean | Standard Deviation | (hr*ng/ml) | 96 hr |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Kharasch MD PhD | Washington University | 3143628796 | kharasch@wustl.edu |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Methadone | Drug | Compare to standard of care for pain management of acute episode of pain |
|
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
| BG002 | 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 |
| BG003 | Morphine-Adults | Morphine standard of Care pain management Morphine: Standard of care for pain management of acute episode of pain |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Methadone comparison to standard of care for pain management Methadone: Compare to standard of care for pain management of acute episode of pain |
| OG003 | Morphine-Adults | Morphine standard of Care pain management Morphine: Standard of care for pain management of acute episode of pain |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 72 hr |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Morphine-Children | Morphine standard of Care pain management Morphine: Standard of care for pain management of acute episode of pain | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 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 | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Morphine-Adults | Morphine standard of Care pain management Morphine: Standard of care for pain management of acute episode of pain | 0 | 12 | 0 | 12 | 0 | 12 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| Male |
|