NCT01325493已完成4 期
Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents
Julia Finkel1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Morphine Equivalent Consumption (mg/kg)
研究概览
简要总结
The purpose of this study is to:
- Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is 10 to 18 years of age
- •The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
- •The subject is scheduled for elective posterior spinal fusion and instrumentation.
- •The subject's parent/legally authorized guardian has given written informed consent to participate
排除标准
- •The subject has a history or a family (parent or sibling) history of malignant hyperthermia
- •The subject is pregnant or nursing.
- •The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
- •The subject has a known or suspected allergy to morphine, remifentanil or ketamine
- •The subject is an ASA classification of 4 or greater (See Appendix I)
- •The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
- •The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
- •The subject had a recent opioid exposure (within 1 month of surgery)
- •The subject is obese (body mass index >30kg/m2)
- •The subject is planned for elective postoperative ventilation
- •The subject has a known ocular disease not permitting pupillometric examination
- •The subject has used any investigation products in the past 30 days
研究组 & 干预措施
Normal Saline
Placebo Comparator
Normal Saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
干预措施: Normal Saline (Drug)
Ketamine
Active Comparator
ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
干预措施: Ketamine (Drug)
结局指标
主要结局
Morphine Equivalent Consumption (mg/kg)
时间窗: at 24, 48, 72, 96 hours post operatively
Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.
次要结局
- Sedation Score(24, 48, 72, 96 hours post operatively)
- Pain Score During Cough.(24, 48, 72, 96 hours post operatively)
- Pain Score at Rest(24, 48, 72, 96 hours post operatively)
研究者
Julia Finkel
Director of Research
Children's National Research Institute
研究点 (1)
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