NCT00654511已完成4 期
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
Children's National Research Institute1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2005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
- 101
- 试验地点
- 1
- 主要终点
- Time to First Morphine Dose
研究概览
简要总结
The primary purpose of this study is:
- To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
- To determine an analgesic dose response relationship for dexmedetomidine.
- Compare recovery characteristics of dexmedetomidine to fentanyl.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All of the following criteria must be met for the potential subject to be eligible for participation:
- •The subject is 2 to 12 years of age
- •The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
- •The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
- •The subject will be hospitalized overnight after surgery
- •The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.
排除标准
- •The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:
- •The subject has a history or a family (parent or sibling) history of malignant hyperthermia
- •The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests.
- •The subject has a known or suspected allergy to opioid analgesics
- •The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
- •The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).
研究组 & 干预措施
Fentanyl 1
Active Comparator
Fentanyl 1 micrograms (mcg)/kilogram (kg)
干预措施: Fentanyl (Drug)
Fentanyl 2
Active Comparator
Fentanyl 2 micrograms (mcg)/kilogram (kg)
干预措施: Fentanyl (Drug)
Dex 3
Experimental
Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)
干预措施: Dexmedetomidine (Drug)
Dex 4
Experimental
Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Time to First Morphine Dose
时间窗: up to 24 hours
Total minutes from study medication administration to time of first morphine dose.
Morphine Rescue
时间窗: up to 24 hours
Total morphine administered in the Post Anesthesia Care Unit (PACU)
次要结局
未报告次要终点
研究者
Julia Finkel
MD
Children's National Research Institute
研究点 (1)
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