To compare the effectiveness of Dexmedetomidine with Ropivacaine and Ropivacaine alone for caudal epidural analgesia in pediatric infraumbilical surgeries in a tertiary care center in Kerala

Dr Alvi Vinod1 个研究点分布在 1 个国家目标入组 68 人开始时间: 2023年2月15日最近更新: 2023年11月2日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 68
试验地点: 1
主要终点: Duration of analgesia assessed by Modified Objective Pain Score greater than 4

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a unicentric observational study to compare the effectiveness of Dexmedetomidine with Ropivacaine and Ropivacaine alone, for caudal epidural analgesia in 68 children of 2-6years of age, belonging to ASA class 1and 2, undergoing elective infraumbilical surgery of less than 1hour duration, to be conducted in a tertiary care center in Kerala. The primary outcome will be duration of analgesia. The secondary outcomes will include duration of sedation, emergence time and duration of motor block.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Participant Blinded

入排标准

年龄范围: 2.00 Year(s) 至 6.00 Year(s)（—）
性别: All

入选标准

•ASA class 1 & 2
•Children undergoing elective infraumbilical surgery less than 1hour duration.

排除标准

•Known allergy to the study drugs
•Suspected coagulopathy
•Infection at the site of block
•History of developmental delay, neurological disease, skeletal deformities, cardiovascular diseases.

结局指标

主要结局

Duration of analgesia assessed by Modified Objective Pain Score greater than 4

时间窗: 10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours

次要结局

Emergence time(Time from end of surgery to opening of eyes spontaneously or on calling.)
Duration of motor block(From time of block to time of spontaneous leg movements)
Sedation using Simple sedation score(10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours)
Heart rate, Mean Arterial Pressure, Respiratory rate, SpO2(Intraoperatively, every 5minutes for the 1st half an hour and then at 10minute intervals.)

研究者

发起方

Dr Alvi Vinod

申办方类型

Other [self]

研究点 (1)

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