Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 主要终点
- Pain perception during LA injection
研究概览
简要总结
This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).
详细描述
The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the operator and the patients will not be applicable due to the difference between the used techniques, however, the statistician will be blinded.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour.
- •Medically fit children (ASA I, II).
- •Children mentally capable of communication.
- •Children aged 6-11 years.
- •First dental visit.
- •Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment.
排除标准
- •Children with a behavioral management problem.
- •Children with known allergy to local anesthetic agents.
- •Parental refusal for participation
研究组 & 干预措施
buzzy device (intervention)
The wings of buzzy device will be kept frozen and once the child is ready, the frozen wing will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic is to be delivered.
干预措施: buzzy device (Device)
Conventinal anasthesia ( control )
- The site of injection will be dried then topical anesthetic gel of 20% benzocaine (Dharma Ophal-S) will be applied. The duration of application of gel will be 1 minute.
- Local anesthetic solution will be delivered using a standard aspirating syringe with 27-gauge, 21 mm short needles.
干预措施: Conventinal anasthesia (Other)
结局指标
主要结局
Pain perception during LA injection
时间窗: one hour
by wong baker scale
次要结局
- Heart rate during injection of local anesthesia.(one hour)
研究者
Mai Gamal Eldeen Hassan Sabra
principal investigator
Cairo University