The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery, Sedation, and Analgesia in Children Given Caudal Anesthesia Plus Bupivacaine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sedation scale and postoperative pain scale (CHIPPS)
研究概览
简要总结
This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery.
详细描述
Summary Background: This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery.
Methods: 40 children between 2 and 10 years of American Society of Anesthesiologist (ASA) I-II stages were randomized and applied caudal anesthesia under general anesthesia. Patients were applied caudal block in addition with saline and 1milliliter/kilograms (mL/kg) bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5 milliliter (mL) saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
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
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children having lower abdominal surgery
排除标准
- •Children with significant respiratory system, circulatory system, liver, and kidney function disorder, history of allergy to the drugs to be studied, those who received analgesic medication before the operation, and those for whom caudal anesthesia is contraindicated
研究组 & 干预措施
Midazolam
1 mL/kg bupivacaine 0.25%.
干预措施: 1 mL/kg bupivacaine 0.25%. (Drug)
saline
5mL rectal saline
干预措施: 1 mL/kg bupivacaine 0.25%. (Drug)
结局指标
主要结局
Sedation scale and postoperative pain scale (CHIPPS)
时间窗: 24 hours
Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
次要结局
未报告次要终点
研究者
SEDAT SAYLAN
Medical Doctor
Karadeniz Technical University