Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain in Children: A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Patient reported pain during needle injection
研究概览
简要总结
Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.
The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.
Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.
详细描述
The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in the mixed dentition stage,
- •Age range 6-12 years old,
- •Need extraction to a maxillary molar,
- •Cooperative and medically free.
排除标准
- •Exclusion will be performed if the parent refused the participation of their children in the research.
结局指标
主要结局
Patient reported pain during needle injection
时间窗: Immediately post injection
Patient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score
次要结局
- Child behaviour during needle injection(Immediately during injection)
- Child and parent satisfaction(Immediately post injection)
- Heart rate(Immediately post injection)
- Oxygen saturation(Immediately post injection)
研究者
Fatma Abdelgawad
Associate Professor
Cairo University