Comparison of caudal clonidine versus caudal dexmedetomidine with bupivacaine for prolongation of postoperative analgesia in children undergoing infraumbilical surgeries.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.TO COMPARE DURATION OF ANALGESIA IN BOTH GROUP.
研究概览
简要总结
Bupivacaine is a long acting amide local anaesthetic. It is most frequently used for caudal anaesthesia in children that provides effective analgesia and motor blockade.Clonidine has been used for sedation, premedication and analgesia.Dexmedetomidine is a potent alpha 2 agonist (selective 2a subtype), widely used to provide analgesia, sedation and anxiolysis.Studies show increase in duration of post-operative analgesia on adding clonidine & dexmedetomidine to local anaesthetic. Both are a safe adjuvant to bupivacaine in pediatric caudal anaesthesia.We therefore decided to study the effects of combination of Bupivacaine and clonidine for prolongation of post-operative analgesia in children were evaluated and compared with the effect of combination of bupivacaine and Dexmedetomidine for prolongation of post-operative analgesia. Hemodynamic changes and side effects was also compared between both group, in children undergoing lower abdominal and perineal surgeries.
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 I ,II AND III PATIENTS SCHEDULED FOR INFRA-UMBILICAL SURGERIES ELECTIVE SURGERIES.
- •CONSENT FROM LEGALLY AUTHORIZED REPRESENTATIVE.
排除标准
- •ASA IV AND V PARENTS AND PATIENT RELATIVE REFUSING TO GIVE CONSENT PATIENTS HAVING PRE-EXISTING CARDIAC, NEUROLOGICAL AND RESPIRATORY DISEASES PATIENTS HAVING COAGULOPATHY PATIENTS WITH CONGENITAL SPINE ANOMALY LOCAL INFECTION/INFLAMMATION.
结局指标
主要结局
1.TO COMPARE DURATION OF ANALGESIA IN BOTH GROUP.
时间窗: 24 HR POST OPERATIVE ASSESSMENT OF PAIN RELIEF SCORE.
2.TO STUDY POSTOPERATIVE PAIN RELIEF IN BOTH GROUP.
时间窗: 24 HR POST OPERATIVE ASSESSMENT OF PAIN RELIEF SCORE.
次要结局
- 1.INTRAOPERATIVE HEMODYNAMIC PARAMETERS.(2.TO COMPARE INTRA OPERATIVE AND POSTOPERATIVE COMPLICATIONS RELATED TO DRUG AND COMPLICATION ASSOCIATED WITH TECHNIQUE.)
研究者
NIRMALKUMAR MISTRY
B.J. MEDICAL COLLEGE AHMEDABAD