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临床试验/NCT02618876
NCT02618876已完成不适用

Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadias Repair

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale

研究概览

简要总结

Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.

2 groups, 30 patients each

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Children undergoing elective Hypospadias repair
  • with American Society of Anesthesiologists (ASA) physical status I
  • age 2-10 years

排除标准

  • Coagulation disorder
  • allergy to study medications
  • major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.

研究组 & 干预措施

Nalbuphine group

Active Comparator

30 children will be given Caudal Bupivacaine plus Nalbuphine.

干预措施: Nalbuphine plus Bupivacaine (Drug)

Control group

Other

30 children will be given Caudal Bupivacaine.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale

时间窗: During 24 h in the postoperative period

次要结局

  • Cortisol level(6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Bakri

Associate professor

Assiut University

研究点 (1)

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