Efficacy and pain perception of a needleless Local Anesthesia delivery system for palatal anesthesia in pediatric dental patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- pain perception and efficacy of local anesthesia using comfort in injector device
研究概览
简要总结
Aim: To evaluate the pain perception and efficacy of a needleless LA delivery system.
**Materials and methods:**64 children aged 4-9 years, who need buccal and palatal infiltration for extractions will be included in the study. By simple randomized sampling they will be assigned to two research groups; Group A (Control group), Group B (Interventional group). Pulse rate, FBRS, Wong Bakers FACES pain rating scale and Modified Behaviour rating scale by Taddio et al will be used to assess pain perception and efficacy. Group A: LA buccal and palatal infiltration will be administered using regular disposable needle and syringe. Group B: LA buccal and palatal infiltration will be administered using the needleless device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
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 1 Classification Children of 4-9 years of age Children of those parents willing to participate in the study.
排除标准
- •Children whose parents do not give consent Children who are allergic to local anesthetic solution and its constituents.
结局指标
主要结局
pain perception and efficacy of local anesthesia using comfort in injector device
时间窗: baseline, during local anesthesia, during treatment, after treatment
次要结局
- time taken for LA administration, dental anxiety(baseline, during treatment & after treatment)
研究者
Dr Sonal Mali
D.Y. Patil University School of Dentistry