NCT00761085已完成不适用
Methadone in Pediatric and Adult Sickle Cell Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
研究概览
简要总结
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Methadone-Children
Active Comparator
Methadone comparison to standard of care for pain management
干预措施: Methadone (Drug)
Morphine-Children
Active Comparator
Morphine standard of Care pain management
干预措施: Morphine (Drug)
Methadone-Adults
Active Comparator
Methadone comparison to standard of care for pain management
干预措施: Methadone (Drug)
Morphine-Adults
Active Comparator
Morphine standard of Care pain management
干预措施: Morphine (Drug)
结局指标
主要结局
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
时间窗: 96 hr
R-Methadone AUC
次要结局
- Pain Relief(72 hr)
研究者
研究点 (1)
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