Comparison of analgesic efficacy of caudal Dexmedetomidine versus caudal Tramadol with Ropivacaine in paediatric infraumblical surgeries: A Prospective randomised study
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
DR MAINA SINGH
Jawahar Lal Nehru Medical College Ajmer Rajasthan
