跳至主要内容
临床试验/NCT02813018
NCT02813018已完成不适用

The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

Yonsei University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
FLACC scale score (Face, Legs, Activity, Cry, Consolability)

研究概览

简要总结

Management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. However, the clinical efficacy of preemptive analgesia is still controversial. In this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities
  • ASA class I and II

排除标准

  • Coagulopathy
  • Neurological disease
  • Allergy to local anesthetics or contraindication to use of ropivacaine
  • Infection at the site of epidural catheter insertion

研究组 & 干预措施

preemptive group

Experimental

Group who will be received ropivacaine bolus and continous infusion 5 minutes before skin incision.

干预措施: 0.2 ml/kg of 0.2% ropivacaine (Procedure)

saline group

Placebo Comparator

Group who will be received saline bolus and continous infusion 5 minutes before skin incision

干预措施: 0.2mg/kg of Normal Saline (Procedure)

结局指标

主要结局

FLACC scale score (Face, Legs, Activity, Cry, Consolability)

时间窗: 0-6 hours after the operation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

The Impact of Preemptive Epidural Analgesia on Acute... | 临床试验