Comparative evaluation of adrenaline and dexmedetomidine as adjunct with lignocaine in enhancing local anesthesia: A split-mouth crossover randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dexmedetomidine is superior as adjunct with lignocaine compared with lignocaine and adrenaline in onset of action and depth of anesthesia
研究概览
简要总结
This study compares and evaluate the efficacy of adrenaline and dexmedetomidine as lignocaine adjunct in enhancing local anesthesia in children. This study is triple blind parallel arm randomized controlled trail and includes total of 40 samples allocated 20 samples for each group by computerized randomization. 2% Lignocaine with adrenaline 1:80,000 will be control group and 2% Lignocaine with dexmedetomidine titrated as 1ml/1mcg. Ethical clearance is obtained from institutional ethical committee before starting study. Informed/ proxy consent is taken from parent/guardian. Local anesthesia is administered with protocol by trained professional based on inclusion criteria. Pain will be assessed with visual analogue scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 6-14years, Children with American Society of Anesthesiologists (ASA) grade I status, Children who require multiple appointments for treatment under local anesthesia as infiltration/block bilaterally.
排除标准
- •Children who are allergic to local anesthetic solution, Children with local infection, abscess and pus discharge, Children who are medically compromised and special children, Children who are not willing and whose parents declined to sign informed consent.
结局指标
主要结局
Dexmedetomidine is superior as adjunct with lignocaine compared with lignocaine and adrenaline in onset of action and depth of anesthesia
时间窗: immediately after local anesthesia administration
次要结局
未报告次要终点
研究者
Dr S Vittal Sai
AMEs dental college hospital and research center