Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- visual analog scale
研究概览
简要总结
safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).
详细描述
After obtaining approval of the local ethics committee of faculty of medicine, Assiut University , Assiut , Egypt , and parent's written informed consent, This randomized double -blinded prospective study conducted on ( 45 ) pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
morphine 2 μg/kg
Children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline.
干预措施: Intrathecal Morphine (Drug)
morphine 5 μg/kg
Children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline.
干预措施: Intrathecal Morphine (Drug)
morphine 10 μg/kg
Children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline.
干预措施: Intrathecal Morphine (Drug)
结局指标
主要结局
visual analog scale
时间窗: 24 hours postoperative .
0- 10 in cm score range will be used to assess pain
次要结局
- rams y sedation score(24 hours)
研究者
Sahar Abdel Baky Mohamed
Assistant Professor of Anesthesia,Intensive care and Pain relief
Assiut University