comparative evaluation of the efficacy of midazolam - nitrous oxide/oxygen and dexmedetomidine - nitrous oxide/oxygen in pediatric dental procedures: a prospective single-blinded cross over study.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- houpt scale, ramsay sedation scale, aldrete score, frankls behaviour rating scale, hemodynamic parameters
研究概览
简要总结
to evaluate the effectiveness of oral midazolam with nitrous oxide - oxygen on sedation and behaviour of children using the houpt scale on administration.
to observe the hemodynamic parameters in children after administration of oral midazolam with nitrous oxide oxygen
to evaluate the effectiveness of intranasal dexmedetomidine with nitrous oxide oxygen on sedation and behaviour of children using the houpt scale on administration
to observe the hemodynamic parameters in children after administration with intranasal dexmedetomidine with nitrous oxide - oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator 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
- •ASA category 1 childs weight within normal range frankl positive or negative behaviour children with atleast 2 carious lesions.
排除标准
- •children with identifiable risk factors for airway obstruction, such as enlarged tonsils, or adenoids, nasal polyps, septal deviation and a Mallampati score of 3 or 4.
结局指标
主要结局
houpt scale, ramsay sedation scale, aldrete score, frankls behaviour rating scale, hemodynamic parameters
时间窗: hemodynamic parameters at baseline and every 15 minutes until the procedure ends
次要结局
- to compare the amnestic effect between oral midazolam with nitrous oxide- oxygen & intranasal dexmedetomidine with nitrous oxide- oxygen using the amnesia test(At baseline & 15 minutes after administration of the drug)
研究者
pooja nellore
mcods mangalore