Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- objective pain score
研究概览
简要总结
Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or vomiting.
The investigators design this protocol to test efficacy of analgesia of three different rates of continuous intravenous sufentanil infusion for postoperative pain management following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare incidence rate of complications for three groups.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient
排除标准
- •Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain.
- •Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.
研究组 & 干预措施
Sufentanil infusion rate 0.02μg•kg-1•h-1
Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours
干预措施: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion (Drug)
Sufentanil infusion rate 0.03μg•kg-1•h-1
Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
干预措施: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion (Drug)
Sufentanil infusion rate 0.04μg•kg-1•h-1
Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours
干预措施: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion (Drug)
结局指标
主要结局
objective pain score
时间窗: up to 48 hours after operation
次要结局
- incidence rate of hypoxia(4h,8h,24h,48h after operation)
研究者
Jin Ni
Department of Anesthesiology
Guangzhou Women and Children's Medical Center