N/A
N=47
Methadone in Pediatric and Adult Sickle Cell Patients
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT00761085 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. — 523; 0; 637; 0 (hr*ng/ml)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Morphine (Drug); Methadone (Drug)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. |
523; 0; 637; 0 | — |
| SECONDARY Pain Relief |
8; 4; 5; 5 | <0.05 sig |
Summary
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00761085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.