Comparative Evaluation of Intranasal Midazolam and Dexmedetomidine in Pediatric Dental Procedure - A Randomized Clinical Trial
试验速览
- 阶段
- 2/3 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 a better anxiolytic and sedative agent than Midazolam
研究概览
简要总结
This study is randomized controlled trial to compare the effectives of Midazolam and Dexmedetomidine as Sedative and Anxiolytic agent during dental procedures among 4 to 9 year old children utilizing split mouth technique. It would be conducted in Department of Pediatric and Preventive Dentistry at Narsinhbhai Patel Dental College & Hospital Visnagar Gujarat India. The primary outcome measures will be Dexmedetomidine is a better anxiolytic and sedative agent than Midazolam in children during dental procedures. The secondary outcome measures will be Intranasal Dexmedetomidine is more effective than Intranasal Midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing treatment for the first time.
- •Patient who exhibit anxious behavior in Frankel behavior rating scale ( score 1 & 2) Requiring two dental procedures under local anaesthesia.
排除标准
- •Patients who do not exhibit anxious behaviour on baseline anxiety scale.
- •Patients with any systemic disease or drug allergy.
结局指标
主要结局
Dexmedetomidine is a better anxiolytic and sedative agent than Midazolam
时间窗: Baseline, During procedure (45 mins) and After procedure (2 hours).
次要结局
- Intranasal Dexmedetomidine is more effective than Midazolam(Baseline, During procedure (45 mins) and After procedure (2 hours))