Effects of Dexmedetomidine as Adjunct to Pudendal Block for Pediatric Penile Surgery
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
- 1st analgesic request time
研究概览
简要总结
Caudal block is often performed to relieve postoperative pain in pediatric urological surgery. Recently, pudendal block is also used in penile surgery and it has advantage because of less side effects such as transient weakness of low extremities, but limited to use in penile surgery. Local anesthesia is a single shot injection, so additional analgesic drugs is required when the effect of local anesthetics are disappeared. Dexmedetomidine, an alpha adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect and potentiates the effect of local anesthetics. There are many studies about the potentiation of the effect of local anesthetics when added to dexmedetomidine in adults, it has been limited in pediatrics. Recent study said that local anesthetics with dexmedetomidine had prolonged duration of analgesia in caudal block, also in ilioinguinal block. Thus it is expected to have a prolonged effect when investigators use dexmedetomidine in pediatrics as well as adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The patients aged between 6 months and 6 years in elective penile surgeries (hypospadias, urethral fistula or stricture after hypospadias repair, penile curvature)
- •American Society of Anesthesiologists (ASA) class I, II
排除标准
- •Coagulopathy
- •allergy to local anesthetics
- •meatal island onlay proximal transverse island flap (MIOPTI) (more than 4 h for the surgery)
- •illiteracy, foreigner
研究组 & 干预措施
DR
dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg
干预措施: Dexmedetomidine (Drug)
DR
dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg
干预措施: Ropivacaine (Drug)
PR
0.25% ropivacaine 0.3ml/kg
干预措施: plain ropivacaine (Drug)
结局指标
主要结局
1st analgesic request time
时间窗: until 24 hours after surgery
time to first rescue medication, assessed up to 24 h (time frame: from the administration of the pudendal block to the first registration of a FLACC≥4) (FLACC: face, legs, activity, cry, consolability)
次要结局
- Emergence delirium evaluated by the pediatric anesthesia emergence delirium scale(The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and through the time of discharge from the PACU, an average of 30 minutes)
- Postoperative pain evaluated by the FLACC scale(The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and 4, 8, 12, 24 h after the surgery.)