Comparative evaluation of pain assessment using Star Pen and Conventional injection technique during inferior alveolar nerve block injection in children aged between 6-10 years. -A Split mouth Randomised Control Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To find out the most efficient local anesthesia administration technique in children aged between 6-10 years.
研究概览
简要总结
This is a split mouth randomised control trial comparing pain perception and pain reaction using Star Pen and Conventional injection technique during inferior alveolar nerve block injection in children aged between 6-10 years. The study will be conducted inBharati Vidyapeeth Dental College and Hospital Pune, India. The purpose of this study is to assess the utilisation of Star Pen : Advanced Dental Anaesthesia Device in routine pediatric dental practice for administration of local anaesthesia. The primary outcome will be To find out the most efficient local anaesthesia administration technique in children aged between 6-10 years. While the secondary outcomes will include Evaluation of pain perception for Star Pen device during IANB injection in children, Evaluation of pain perception for conventional cartridge syringe during IANB injection in children, Evaluation of pain reaction for Star Pen device during IANB injection in children, Evaluation of pain reaction for conventional cartridge syringe during IANB injection in children, To compare pain perception and pain reaction of Star pen device and conventional cartridge syringe during IANB injection in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients requiring bilateral inferior alveolar nerve block injection for further dental treatment.
- •Healthy (ASA-I) patients in the age group 3)Cooperative patients (Frankel behaviour rating 3 and 4).
排除标准
- •Children with special health care needs.
- •Children with any systemic complications.
- •Very uncooperative patients (Frankel behaviour rating 1 and 2) 4)Children with known allergies to local anesthesia solution.
结局指标
主要结局
To find out the most efficient local anesthesia administration technique in children aged between 6-10 years.
时间窗: There will be a wash out period of 2 weeks between both injection techniques
次要结局
- Evaluation of pain perception for conventional cartridge syringe during IANB injection in children.
- Evaluation of pain perception for Star Pen device during IANB injection in children.
- Evaluation of pain reaction for Star Pen device during IANB injection in children.(Pain reaction will be recorded right after the injection)
- Evaluation of pain reaction for conventional cartridge syringe during IANB injection in children.(Pain reaction will be evaluated right after the injection)
- To compare pain perception and reaction for star pen device and conventional local anaesthesia technique during IANB injection in children(There will be a wash out period of 2 weeks between both injection techniques)
研究者
Dr Swanandi Kelkar
Bharati VidyapeethDeemed to be University Dental College and Hospital Pune