Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- pain score
研究概览
简要总结
Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.
详细描述
After receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 S(+)-ketamine. All patients will receive caudal block anesthesia with marcaine. Cardiovascular monitoring will be assessed during operation. Follow up will continue for 24 hours after caudal block. Duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. Data will be analyzed statistically by Chi square, t test and nonparametric tests.
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, Care Provider)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged < = 12 years
- •Children scheduled for elective orthopedic surgery with caudal block
- •ASA score < = 3
排除标准
- •Contraindication for caudal block such as vertebral defect or infection at the site of block
- •Disagreement of parents
- •Patient's age > 12 years
- •ASA score > = 4
研究组 & 干预措施
1
epidural s(+)-ketamine for supplementation of caudal anesthesia
干预措施: S(+)-ketamine (Drug)
2
intravenous ketamine for supplementation of caudal anesthesia
干预措施: S(+)-ketamine (Drug)
结局指标
主要结局
pain score
时间窗: 24 hours after anesthesia
次要结局
- analgesic request(24 hours after anesthesia)