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临床试验/CTRI/2025/07/090175
CTRI/2025/07/090175尚未招募不适用

Comparison of analgesic efficacy of caudal Dexmedetomidine versus caudal Tramadol with Ropivacaine in paediatric infraumblical surgeries: A Prospective randomised study

J L N Medical college1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年7月15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
34
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

This will be a prospective randomised study conducted to evaluate injection dexmedetomidine 2mcg/kg and inj. tramadol 2mg/kg as an adjuvant with injection ropivacaine 0.75% caudally in paediatric patient who are between 1 to 8yr old 

ASA grade 1 or 2 with exemption of all exclusion criteria mention above and undergoing infraumblical surgeries under caudal analgesia with primary objective of  comparing the duration of analgesia secondary objective being onset and duration  of sensory block and cardiovascular effect, side effect. Participant will be allocated in two group each with 17 sample size. Group RD receiving injection dexmedetomidine and group RT receiving injection Tramadol as an adjuvant with local anaesthetic caudal block in above mention doses. Pre anaesthetic evaluation will be done previous day, necessary pre medication will be given , informed written consent will be taken prior to surgery. All emergency drugs and equipment will kept ready in prior. Under all aseptic precaution respective drug will be given caudally to respective group of patient. Patient will be monitored  intra operative  and post operatively . All the parameter will be recorded at pre described interval and documented, data will  be analyses statically using standard qualitative and quantitative test. Continuous variable will be analyse using student pair test and categorical variable will be analysed using chi-square test. P value is less than 0.5 will be consider significant.

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 8.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2 undergoing elective infraumblical surgeries.

排除标准

  • Patient refusal patient having history or evidence of infection at the back, allergy to drugs ,bleeding /coagulation disorder history of developmental delay sepsis.

结局指标

主要结局

Duration of analgesia

时间窗: assessment of visual analogue for pain in post operative period at immediately after shifting post operative unit after 1hr,2hr, 3hr, 4hr, 6hr, 8hr, 10hr

次要结局

  • the duration of motor block, post operative(5-point sedation score emergence time. FLACC pain score with its 0-10 score range each patient pain intensity will assessed 1hr 2hr 3hr 4hr 5hr 6hr,every 3hr till 12hr)

研究者

发起方
J L N Medical college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR MAINA SINGH

Jawahar Lal Nehru Medical College Ajmer Rajasthan

研究点 (1)

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