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临床试验/CTRI/2026/01/100289
CTRI/2026/01/100289尚未招募4 期

A Randomized Controlled study to evaluate Effectivness of Tramadol as an Adjuvant to caudal Ropivacaine for postoperative Analgesia in lower Abdominal surgeries in Pediatric Patients Under Anesthesia at SMS Medical college Jaipur

SMS MEDICAL COLLAGE JAIPUR1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This study is a hospital-based, randomized interventional trial conducted at SMS Medical College, Jaipur, to evaluate the effectiveness of tramadol as an adjuvant to caudal ropivacaine for postoperative analgesia in pediatric patients undergoing lower abdominal surgeries under general anesthesia. A total of 60 children aged 1–5 years, belonging to ASA physical status I–II, will be randomly allocated into two groups. Group I will receive caudal ropivacaine 0.2% (1 ml/kg), while Group II will receive caudal ropivacaine 0.2% (1 ml/kg) with tramadol 2 mg/kg. The primary outcome will be time to first rescue analgesia within 24 hours postoperatively. Secondary outcomes include postoperative pain assessment using FLACC scale, sedation assessment using Wisconsin sedation score, hemodynamic parameters, number of rescue analgesic doses, and incidence of adverse effects. The study aims to determine whether addition of tramadol prolongs duration and improves quality of postoperative analgesia without increasing adverse effects.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Parents/ Guardian willing to give consent for the study 2)Children undergoing elective lower abdominal surgery 3)Patients of either sex 4)Age ranging between 1-5 years of age 5)ASA Grade I and II 6)Weight less than 20 kilogram 5).

排除标准

  • History of allergic reactions to drugs used in study 2)Local infection at the proposed site of puncture for caudal block 3)History of developmental dealy 4)History of neurological deficit or verbal deformity 5)Patients on anticoagulant therapy and History of coagulation disorders 6)Patient shuld not be a part of any other study.

研究者

发起方
SMS MEDICAL COLLAGE JAIPUR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr RAMA CHATTERJEE

SMS MEDICAL COLLAGE JAIPUR

研究点 (1)

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