The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- VAS
研究概览
简要总结
the porpose of study to assess The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children
详细描述
This study to assess The Effectiveness of Sweet Solution Versus Cryotherapy in Reducing Pain During Administration of Local Anesthesia Among Children
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
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with behavior rating score 2,3 or 4 of Frankl's behavior rating scale
- •children aged 6-11 years requiring dental injections for pulpectomy, root canal treatment, or extraction procedures for primary and permanent mandibular molars.
排除标准
- •Allergy to lidocaine
- •Redness at the site of injection؛ and a history of abscess, sinus tract, or fistula associated with the teeth.
- •Children with special health care needs.
- •Children suffering from systemic diseases.
- •Extremely uncooperative children.
研究组 & 干预措施
apply normal treatment with topical anesthesia before admenistration of local anesthesia
干预措施: topical anesthesia (Behavioral)
apply treatment with cryotherapy as analgesic before admenistration of local anesthesia
干预措施: Cryotherapy (Behavioral)
apply treatment with sucrose solution as analgesic before admenistration of local anesthesia
干预措施: sucrose solution (Behavioral)
结局指标
主要结局
VAS
时间窗: up to twelve weeks
a simple, 10-cm line used to measure pain intensity in children, with word anchors at each end like "no pain" and "worst possible pain". Children are asked to mark the point on the line that represents their pain level, and the distance from the "no pain" anchor is used to calculate the score. While VAS is generally considered reliable for children 5 years and older, some studies suggest younger children may struggle with the conceptual complexity.
FLACC scale
时间窗: up to twelve weeks
a behavioral pain assessment tool used for children, especially those who cannot verbally express their pain. It stands for Face, Legs, Activity, Cry, and Consolability. The FLACC scale is used to assess pain in infants and children from birth and older, including those with developmental delays. It's a way to understand pain by observing facial expressions and behavioral patterns. Each of the five categories is scored on a 0-2 scale, resulting in a total pain score from 0 to 10
次要结局
未报告次要终点
研究者
Manwa Ayed
Principal Investigator
Mansoura University