NCT00921843已完成4 期
Methadone in Pediatric Anesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- R-methadone Plasma AUC 0-96hr/Dose
研究概览
简要总结
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
- •Signed, written, informed consent from legal guardians and assent from patient
排除标准
- •History of or known liver or kidney disease
研究组 & 干预措施
Methadone 0.1mg/kg
Experimental
Methadone 0.1mg/kg
干预措施: Methadone 0.1mg/kg (Drug)
Methadone 0.2mg/kg
Experimental
Methadone 0.2mg/kg
干预措施: Methadone 0.2mg/kg (Drug)
Methadone 0.3mg/kg
Experimental
Methadone 0.3mg/kg
干预措施: Methadone 0.3mg/kg (Drug)
Control
Placebo Comparator
No methadone
干预措施: Methadone 0.2mg/kg (Drug)
Control
Placebo Comparator
No methadone
干预措施: Control (Drug)
结局指标
主要结局
R-methadone Plasma AUC 0-96hr/Dose
时间窗: 96 hr
次要结局
未报告次要终点
研究者
Evan Kharasch
Vice-Chair for Innovation, Director of Research Entrepreneurship
Duke University
研究点 (1)
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