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临床试验/NCT07121764
NCT07121764已完成4 期

Comparison of Post-Operative Analgesia With Bupivacaine Alone Versus Bupivacaine and Dexmedetomidine, in Caudal Block for Infra-Umbilical Surgeries in Children

Allama Iqbal Teaching Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Analgesia Duration

研究概览

简要总结

This study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. This block helps reduce pain after surgery.

The study will compare two types of caudal injections:

One group will receive Bupivacaine alone, a commonly used local anesthetic.

The other group will receive Bupivacaine combined with Dexmedetomidine, a medicine that might help the pain relief last longer.

The main question the researchers want to answer is:

Does adding Dexmedetomidine to Bupivacaine increase the duration of pain relief after surgery in children?

Researchers will also look at:

How long it takes before the child needs the first dose of pain medicine after surgery

How much pain medicine is used in the first 24 hours

How long any movement problems (motor block) last

Whether there are any side effects

Each child will be randomly assigned (like flipping a coin) to one of the two groups. The caudal block will be done after the surgery is completed, while the child is still under anesthesia. The nurse assessing the child's pain will not know which medicine the child received.

Children will be monitored for pain using a standard scoring system (FLACC scale) every few hours after surgery. If the pain score is high (7 or more), the child will receive intravenous paracetamol. Researchers will record how long the pain relief lasts, when the first pain medicine is needed, and the total amount of pain medicine used in the first 24 hours.

The study aims to help doctors choose the most effective and safe method to reduce post-surgery pain in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Elective infra-umbilical Surgeries
  • ASA Status I and II

排除标准

  • Chronic systemic illness (cardiovascular, pulmonary or renal disease, hepatic impairment)
  • Allergy to local anesthetics
  • Coagulation disorder
  • Local skin infection
  • Neuropathy

研究组 & 干预措施

Monotherapy

Active Comparator

Bupivacaine alone

干预措施: Bupivacaine %0.25 (isobaric) (Drug)

Combination therapy

Experimental

Bupivacaine with Dexmedetomidine

干预措施: Dexmedetomidine & Bupivacaine. (Drug)

结局指标

主要结局

Analgesia Duration

时间窗: From surgery to 24-hours post operatively

Duration of post-operative pain free time (hours): time from surgery to FLACC score ≥7 needing rescue analgesia

次要结局

未报告次要终点

研究者

发起方
Allama Iqbal Teaching Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sajid Ullah

Principal Investigator

Allama Iqbal Teaching Hospital

研究点 (1)

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