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临床试验/NCT01990573
NCT01990573已完成不适用

Methadone in Pediatric Anesthesia II

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年4月10日最近更新:
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
51
试验地点
1
主要终点
Pain Scores

研究概览

简要总结

Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).

详细描述

Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.

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
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

methadone HCl 0.4 mg/kg

Experimental

0.4mg/kg IV methadon HCl

干预措施: 0.4mg/kg IV methadon HCl (Drug)

methadone HCl 0.3 mg/kg

Experimental

0.3mg/kg IV methadone HCl

干预措施: 0.3mg/kg IV methadone HCl (Drug)

control group

Active Comparator

control no methadone, standard of care opioids.

干预措施: control no methadone (Other)

结局指标

主要结局

Pain Scores

时间窗: 6 days

Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .

Total Opioid Consumption (Morphine Equivalent)

时间窗: 6 days

Measure of overall morphine consumption

次要结局

  • Cmax of R and S Methadone(96 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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