Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children: A Randomised Controlled Double Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Time to first analgesic requirement
研究概览
简要总结
The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.
详细描述
Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of dexmedetomidine is the most beneficial remains unknown.
The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal bupivacaine in children undergoing infra-umbilical surgery.
75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with American Society of Anesthesiologists (ASA) - I
- •Scheduled for lower abdominal and perineal surgery
- •Under general anesthesia
排除标准
- •Hypersensitivity to any local anesthetics
- •Patient has history of allergy, intolerance, or reaction to dexmedetomidine
- •Infections at puncture sites
- •Bleeding diathesis
- •Preexisting neurological disease
- •Children with uncorrected cardiac lesions
- •Children with heart block
研究组 & 干预措施
caudal Dexmedetomidine
Drug:Caudal Bupivacaine 0.25% 1ml/kg .
Drug:caudal Dexmedetomidine 1μg /kg.
Intravenous :10 ml normal saline
Anesthesia was induced and maintained with sevoflurane
干预措施: Caudal Dexmedetomidine (Drug)
Intravenous Dexmedetomidine
Drug:Caudal bupivacaine 0.25% 1ml/kg
Drug: Intravenous dexmedetomidine 1µg/kg in a 10 ml volume normal saline
Anesthesia was induced and maintained with sevoflurane
干预措施: Intravenous dexmedetomidine (Drug)
Placebo
Caudal: bupivacaine 0.25% 1ml/kg .
Intravenous: 10 ml Normal saline
Anesthesia was induced and maintained with sevoflurane
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first analgesic requirement
时间窗: 24 hours
Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4
次要结局
- the incidence of emergence agitation(2 hours)
- Postoperative behaviour scores(2 hours)
- Blood pressure Perioperative blood pressure readings(2 hours)
- Side effects(24 hours)
- Sevoflurane concentration(1 hour)
- Heart Rate(2 hours)
- Postoperative pain scores(24 hours)
研究者
Khaled Radian Al-zaben
Dr
University of Jordan