跳至主要内容
临床试验/NCT05617976
NCT05617976已完成不适用

Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Ain Shams University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
duration of analgesia

研究概览

简要总结

Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.

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
None

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I, II.
  • Age 1-3 years.
  • Patients scheduled for hypospadias repair surgeries.

排除标准

  • ASA III, IV.
  • Signs of infection at site of injection.
  • Known coagulopathy disorder.
  • Mental and / or developmental retardation.

结局指标

主要结局

duration of analgesia

时间窗: 24hours

Time to first analgesia request (TFAR)

Quality of Postoperative analgesia

时间窗: 24 hours

Face legs activity cry consolablity score (FLACC) (0-10) Score: 0, no pain; 1-3, mild pain; 4-7, moderate pain; 8-10, severe pain

次要结局

  • analgesic consumption(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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