Efficacy and safety of plain 2 percent lignocaine versus 3 percent mepivacaine in pediatric dental procedures: A randomized controlled clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 3% mepivacaine may show less pain, fast onset and with less duration when compared to lignocaine
研究概览
简要总结
This study compares the efficacy and safety of 2% lignocaine hydrochloride without vasoconstrictor with 3% Mepivacaine hydrochloride without vasoconstrictor as local anesthesia agent in pediatric dental procedures. This study is triple blind randomized controlled split mouth study involving total of 24 samples allocated to each groups equally through computerized randomization. 2% lignocaine hydrochloride without vasoconstrictor will be control group and 3% mepivacaine hydrochloride without vasoconstrictor as comparator group. 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 Wong bakers pain rating 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
3% mepivacaine may show less pain, fast onset and with less duration when compared to lignocaine
时间窗: 3% mepivacaine may show less pain, fast onset and with less duration when compared to lignocaine
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