Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in pain scores
研究概览
简要总结
Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are in need of extraction of maxillary posterior teeth.
- •Children free of any systemic disease or special health care needs (ASA I).
- •Children with no learning disabilities.
- •Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
- •Patients whose parents will give consent to participate.
排除标准
- •Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
- •Signs of reversible pulpitis.
- •Restorable tooth.
- •Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
- •Patients with acute oral or facial infection (swelling and/or cellulites )
结局指标
主要结局
Change in pain scores
时间窗: Baseline and up to 1 hour
Visual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain.
Change in child's behavior
时间窗: During the procedure
Sound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections. Total scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort
次要结局
未报告次要终点