Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children.
It has two phases:
Phase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey.
Phase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations.
The primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group 7-11 years
- •Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
- •Frankl behavior scale 3 and 4
排除标准
- •Failure to provide assent or consent
- •Allergy from local anesthetic solution
- •Systemic diseases such as diabetes that could affect pain perception
- •History of abscess or fistula at site of injection
研究组 & 干预措施
Precooling + sweet tasting solution + topical anaesthesia
干预措施: Dental anesthesia (Behavioral)
Precooling + sweet tasting solution group
干预措施: Dental anesthesia (Behavioral)
Sweet tasting solution group
干预措施: Dental anesthesia (Behavioral)
Sweet tasting solution + topical anaesthesia group
干预措施: Dental anesthesia (Behavioral)
Topical anaesthesia group
干预措施: Dental anesthesia (Behavioral)
Precooling group
干预措施: Dental anesthesia (Behavioral)
Precooling + topical anaesthesia group
干预措施: Dental anesthesia (Behavioral)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Immediately after intervention
Pain Intensity assessed by visual analogue scale
次要结局
- Phase 1 outcome(After intervention)
- Heart Rate(Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection)
- Sound, eye and motor scale (SEM) scale(During needle injection)
- Oxygen saturation(Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage)
研究者
Nada Mohammed Farouk
Principal investigator
British University In Egypt