Comparative Evaluation Of Two Intranasal Sedative Agents Among Children Undergoing Invasive Dental Procedures: A Crossover Split Mouth Randomized Clinical 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
- To compare the effect of intranasal dexmedetomidine and intranasal midazolam paediatric dental patients undergoing pulp therapies and extraction
研究概览
简要总结
Aim:
The Aim of the study is to compare and evaluate the effect of intranasal dexmedetomidine and intranasal midazolam as a conscious sedation among children with the 4-10 years
Methodology
Patients that come under inclusion criteria are allotted to the groups. Then samples are subjected to stratified block randomisation based on the order of the study.The study sample, examiner and analyser are blinded. The drug will be administered with the help of atomisation device. The drug acceptance and side effects will be recorded according to scale given by Rakaf et. al 2001. The rate of sedation and behaviour will be analysed using Houpt behaviour scale at preoperative, intraoperative and postoperative period. The mean data will be recorded and data will be subjected to statistical analysis.
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
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Anxious paediatric patients aged 4–10 years with negative and definitely negative behavioural rating.
- •Belonging to American society of Anaesthesiologists (ASA) physical status I.
- •Whose treatment requires bilateral pulp therapy (pulpotomy/pulpectomy) in lower two quadrants under inferior alveolar nerve block.
- •Whose treatment requires bilateral extraction in lower two quadrants under inferior alveolar nerve block Children with no enlarged tonsils, no problem with neck movements and no oversized tongue.
- •Children with optimal SpO2 saturation.
- •Treatment modality only for first or second primary molars on both the sides.
排除标准
- •Children with cognitive impairment Breathing difficulties, History of systemic illness, Hypersensitivity to midazolam/ Children with congenital heart disease.
- •Children on central nervous system (CNS) depressant drugs.
结局指标
主要结局
To compare the effect of intranasal dexmedetomidine and intranasal midazolam paediatric dental patients undergoing pulp therapies and extraction
时间窗: preoperative, 5 minutes after application and postoperative
次要结局
- To evaluate & compare the rate of acceptance & side effects of intranasal sedative agents.(Preoperative 5 minutes after application & postoperative)
研究者
KASHYAP B
Student, Department of Pedodontics