跳至主要内容
临床试验/CTRI/2025/08/093790
CTRI/2025/08/093790尚未招募2 期

Efficacy of dexamethasone versus fentanyl in addition to levobupivacaine in caudal anaesthesia in paediatric postop patients: A randomized controlled trial.

Dr Rakshit Maheshwari1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
102
试验地点
1
主要终点
Time of administration of first rescue analgesia (Inj PCM 15 mg/kg)

研究概览

简要总结

Caudal block is safe, effective and reliable analgesic technique widely recommended in paediatric surgeries.

Caudal block with only local anaesthesia offers superior short term analgesia. As a result, different adjuncts like dexamethasone, fentanyl, ketamine, morphine are used to prolong the analgesic effect.

We hypothesize that there is no significant difference in the efficacy of dexamethasone and fentanyl as an adjunct to local anaesthesia (levobupivacaine) in caudal block for postoperative analgesia and early motor function recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • American society of anaesthesiologist(ASA) physical status I and II 2)In infraumibilical surgeries posted for general anaesthesia with caudal block 3)Duration of surgery less than 120 minutes 4)Post anaesthesia care unit(PACU) stay less than 60 minutes.

排除标准

  • Coagulopathies 2)Allergy to study drugs 3)Spinal deformities 4)Procedural failure.

结局指标

主要结局

Time of administration of first rescue analgesia (Inj PCM 15 mg/kg)

时间窗: 24 hour

次要结局

  • Motor function recovery postoperatively in PACU using modified bromage scale(1 hour)

研究者

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

Dr Rakshit Maheshwari

Kalinga Institute of Medical Sciences

研究点 (1)

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