Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- First time of rescue analgesia requirement
研究概览
简要总结
Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
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
- 1 Year 至 7 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged 1-7 years
- •American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.
排除标准
- •Developmental delay
- •Psychological or neurological disorders
- •Difficult airway
- •Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
研究组 & 干预措施
Dexmedetomidine
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
干预措施: Dexmedetomidine (Drug)
Ketamine
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
干预措施: Ketamine (Drug)
Magnesium sulphate
0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.
干预措施: Magnesium sulphate (Drug)
结局指标
主要结局
First time of rescue analgesia requirement
时间窗: 24 hours postoperatively
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).
次要结局
- The incidence of adverse effects(24 hours postoperatively)
- Pain score(24 hours postoperatively)
- Total consumption of rescue analgesia(24 hours postoperatively)
研究者
Gamal Hendawy Shams
Lecturer
Kafrelsheikh University