NCT00654329已完成4 期
Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
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8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
- Incidence of Pain
研究概览
简要总结
A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
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, Investigator)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation:
- •The subject is 6 months to 6 years of age
- •The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
- •The subject is scheduled for elective bilateral myringotomy with tube placement
- •The subject's parent/legally authorized guardian has given written informed consent to participate
排除标准
- •Subjects will be excluded from study participation if any of the following exclusion criteria exists:
- •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 or dexmedetomidine
- •The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
- •The subject has know central nervous system disease or neurological impairment
- •The subject is an ASA classification of 3 or greater (See Appendix 1)
- •The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
- •The subject refuses inhalation induction
- •The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)
研究组 & 干预措施
Dexmedetomidine 1microgram/kilogram
Experimental
Dexmedetomidine 1microgram/kilogram intranasal
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 2 micrograms/kilogram
Experimental
Dexmedetomidine 2 micrograms/kilogram intranasal
干预措施: Dexmedetomidine (Drug)
Fentanyl 2 micrograms/kilogram
Active Comparator
Fentanyl 2 micrograms/kilogram intranasal
干预措施: Fentanyl (Drug)
Normal saline placebo
Placebo Comparator
Normal saline placebo intranasal
干预措施: Saline (Drug)
结局指标
主要结局
Incidence of Pain
时间窗: up to 24 hours
Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)
次要结局
- Length of Stay in PACU(up to 24 hours)
研究者
研究点 (1)
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