Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block for Pediatrics Undergoing Inguinal Hernia Surgery: A Comparative Prospective Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- duration of postoperative analgesia
研究概览
简要总结
The goal of This prospective, randomized, double-blind comparative study is to compare the efficacy of dexamethasone and dexmedetomidine as adjuvants to bupivacaine 0.125% in caudal epidural block for pediatrics undergoing inguinal hernia surgery, aged 2-6 years.
of Both sex.
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
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 2-6 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I and II.
- •Scheduled for inguinal hernia surgery
排除标准
- •Parents or legal guardians refusal.
- •Known hypersensitivity to any study drugs.
- •Abnormal sacral anatomy
- •Local infection at the injection site.
- •Neurological disease.
- •Coagulopathy.
- •Mental retardation.
研究组 & 干预措施
group A will receive Bupivacaine + Dexmedetomidine
Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexmedetomidine 1.5 mcg/kg for post operative analgesia.
干预措施: Dexmedetomidine (Drug)
group B will receive Bupivacaine + Dexamethasone
Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexamethasone 0.2 mg/kg for post operative analgesia.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
duration of postoperative analgesia
时间窗: "Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour"
FLACC scale (Face, Leg, Activity, Crying, Consolability) total score of 0-10 ,so the duration of analgesia will be defined as the time from caudal injection to the point when FLACC score exceeds 4.
次要结局
- Pain score("Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour")
研究者
Reham Ragab Younis
Resident-Anesthesia, ICU and pain management department-sohag hospital university
Sohag University