Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity
研究概览
简要总结
The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.
详细描述
Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.
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)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 5-12 years of age.
- •Positive or definitely positive behavior on Frankl scale.6
- •Children receiving treatment on the dental chair.
- •Free from allergies to topical anesthetic used in the study.
- •Parental consent for child participation in the study.
排除标准
- •Those in need of treatment under general anesthesia will be excluded from the study.
- •Children with allergies from topical anesthesia
研究组 & 干预措施
Buzzy
Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.
干预措施: Adminstration Technique using Buzzy external distractor (Device)
Buzzy
Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.
干预措施: Topical Anesthetic (Drug)
Control
Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only.
干预措施: Topical Anesthetic (Drug)
结局指标
主要结局
Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity
时间窗: Procedure (immediately after the administration of Dental anesthesia)
Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful).
次要结局
- Parents Perception for the child tolerance of pain; Observational Pain rating scale(Procedure (immediately after the administration of Dental anesthesia.))
- External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).(Procedure (immediately during and after the administration of Dental anesthesia.))
- Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)(Procedure (immediately during and after the administration of Dental anesthesia.))
研究者
Jehan AlHumaid
Associate Professor
Imam Abdulrahman Bin Faisal University