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临床试验/CTRI/2024/04/065745
CTRI/2024/04/065745尚未招募不适用

A comparative study of Fentanyl and Clonidine as additives to plain Bupivacaine in caudal anaesthesia in children for postoperative analgesia in Infraumbilical and Genitourinary Surgeries.

Dr Vaidehi Chavan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare the duration of analgesia in the postoperative period.

研究概览

简要总结

Caudal
anesthesia is a common regional technique in pediatric patients ,in children
caudal anesthesia is typically combined with general anesthesia for
intraoperative supplementation and postoperative analgesia. Children
experience pain in the same way as adults, though they may be unable to
describe the pain ,postoperative analgesia in children is a challenging
hurdle before the anesthesiologist. Good and prolonged postoperative
analgesia not only relieves pain in children but also relieves anxiety in
parents1. Caudal analgesia is an accepted and popular method of
providing intra operative and postoperative analgesia for genitourinary and
inguinal surgeries in children, as it is safe, reliable and easy to administer1.

Bupivacaine is the most commonly used local anesthetic for caudal block but its limitation is short duration of action, about 4-6 hours when administered as a single shot technique. Prolongation of caudal block can be achieved by addition of various additives like epinephrine, ketamine, opioids, clonidine, dexmedetomidine and neostigmine. The addition of adjuncts not only increases the effectiveness of a local anesthetic by prolonging and intensifying the sensory blockade but also causes reduction in dose of local anaesthetic agents use.

Ketamine has potential for neurotoxic effects, if inadvertently injected intrathecally and neostigmine is accompanied by 30% incidence of vomiting. Opioids and local anesthetics administered together have synergistic analgesic effects, but carries the risk of respiratory depression. Because of its rapid onset of action and high lipid solubility, fentanyl is considered to be a suitable opioid for caudal administration. The role of Clonidine as an analgesic administered by caudal route is now well established in children. Co-administration of caudal Clonidine with Bupivacaine has been found to prolong analgesia without significant respiratory depression after epidural administration.

This study is to assess the efficacy and safety of Fentanyl and Clonidine in low doses as an adjuvant to Bupivacaine for postoperative analgesia in pediatric genitourinary and infraumbilical surgeries.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status 1 and 2,
  • Elective infra-umbilical and genitourinary surgeries.

排除标准

  • Parent unwillingness
  • Infection at block site
  • Bleeding diathesis.

结局指标

主要结局

To compare the duration of analgesia in the postoperative period.

时间窗: 0 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr.

次要结局

  • To compare the duration of post operative analgesia provided by each group and associated side effects.(0 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr.)

研究者

发起方
Dr Vaidehi Chavan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vaidehi Chavan

BJGMC and SGH, Pune

研究点 (1)

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