Comparative evaluation of anxiety and pain during local anesthesia administration by Conventional Syringe and Electronic Dental Anesthesia Device in children : A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of Anxiety and Pain during local anesthesia administration using Electronic Dental Anesthesia Device (Star Pen®) as compared to Conventional Syringe in Children.
研究概览
简要总结
Pediatric dental anxiety is often triggered by injections, which are feared due to their psychological and visual impact. While local anesthesia alleviates discomfort, its administration can still be distressing for children, as anxious patients tend to perceive more pain. Various techniques, such as topical anesthetics, slow injection methods, and distraction, aim to reduce this pain. However, some discomfort persists, even with these methods. The Electronic Dental Anesthesia device, which offers adjustable speeds and time/pressure control, presents a promising alternative to traditional syringes, potentially minimizing pain. This study aims to compare anxiety and pain levels in children receiving local anesthesia via the conventional syringe versus the Electronic Dental Anesthesia device. Objective of the study is to evaluate and compare the anxiety and pain during local anesthesia administration by Conventional syringe and Electronic Dental Anesthesia device in children
This is a parallel arm randomized control trial evaluating anxiety and pain during local anesthesia administration by Conventional syringe and Electronic Dental Anesthesia device in children. The pre-procedural pulse rate will be monitored using pulse oximeter and anxiety score by Venhams Picture Scale will be measured prior to procedure. Topical anaesthetic will be applied and local anesthesia will be given with 2% lignocaine 1:80,000 by Conventional Syringe and Electronic Dental Anesthesia Device in Group I and Group II respectively. The Pain will be assessed during the local anesthesia administration by SEM Scale by a trained pediatric dentist. Immediately after local anesthesia administration Anxiety will be recorded using pulse oximeter and Venham’s picture scale. The Self-administered Wong Baker Faces Pain Rating scale will be used to record pain. Expected outcome of the study is reduction in anxiety and pain during local anaesthesia administration using Electronic dental anesthesia device as compared to Conventional syringe in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children undergoing dental treatment requiring local anesthesia Children in the age group of 6 to 12 years Children with Frankls behavior rating scale of positive and definitely positive Children who are willing to undergo treatment.
排除标准
- •Children with a diagnosed systemic disease and special healthcare needs.
- •Children with a known history of allergy to local anesthetic agents.
结局指标
主要结局
Reduction of Anxiety and Pain during local anesthesia administration using Electronic Dental Anesthesia Device (Star Pen®) as compared to Conventional Syringe in Children.
时间窗: Anxiety will be recorded before and immediately after the local anesthesia administration using pulse oximeter and Venham’s picture scale. | Pain will be assessed during the local anesthesia administration by SEM Scale by a trained pediatric dentist | Self administered Wong Baker Faces Pain Rating scale will be used immediately after local anesthesia administration.
次要结局
- Reduction of Anxiety and Pain during local anesthesia administration using Electronic Dental Anesthesia Device as compared to Conventional Syringe in Children.(Anxiety will be recorded before and immediately after the local anesthesia administration using pulse oximeter and Venham’s picture scale.)
研究者
Dr Sharvari Itankar
K.L.E.V.K Institute of Dental Science