Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Amount of Post-Operative Rescue Morphine Required for Analgesia
研究概览
简要总结
The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.
详细描述
Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.
As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.
排除标准
- •Children less than 3 years
- •Children with uncorrected cardiac lesions
- •Children with heart block or liver impairment
- •Children with American Society of Anesthesiology Class 3 or 4.
研究组 & 干预措施
Dexmedetomidine 0.75 mcg/kg
Intraoperative administration for analgesia.
干预措施: Dexmedetomidine 0.75 mcg/kg (Drug)
Dexmedetomidine 1mcg/kg
Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia
干预措施: Dexmedetomidine 1 mcg/kg (Drug)
Morphine 50 mcg/kg
Intra-operative administration of morphine 50 mcg/kg for analgesia
干预措施: Morphine 50 mcg/kg (Drug)
Morphine 100mcg/kg
Intra-operative administration of morphine 100mcg/kg for analgesia
干预措施: Morphine 100 mcg/kg (Drug)
结局指标
主要结局
Amount of Post-Operative Rescue Morphine Required for Analgesia
时间窗: From admission to discharge from PACU, up to 1 hour
次要结局
- Morphine Rescue Doses Needed by Participants(From admission to discharge from PACU, up to 1 hour)
- Duration of Oxygen Supplementation(From admission to PACU until room air saturations greater than or equal to 95% for 5 minutes)
- Time to PACU Discharge Readiness(From admission to discharge from PACU, no time limit)
- Number of Participants With Emergence Agitation(From admission to discharge from PACU, no time limit)
- Number of Participants With Postoperative Complications(From admission to discharge from PACU, up to 1 hour)
研究者
Olutoyin A. Olutoye
Associate Professor of Anesthesiology & Pediatrics
Baylor College of Medicine