A comparative evaluation of pain perception and postoperative pain in children with pre cooled injection sites using popsicles for local anaesthesia: a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- pain perception
研究概览
简要总结
Title: A Comparative Evaluation of Pain Perception and Postoperative Pain in Children with Pre-Cooled Injection Sites Using Popsicles for Local Anaesthesia: A Randomized Controlled Trial
Objective: This study aims to assess the effectiveness of pre-cooling injection sites using popsicles in reducing pain perception during local anaesthesia administration and postoperative pain post extraction in children.
Study Design: A randomized controlled trial with two groups—one receiving pre-cooling with popsicles before local anaesthesia and the other receiving standard local anaesthesia without pre-cooling.
Participants: Children requiring dental procedures under local anaesthesia.
Intervention: The experimental group will receive popsicle application to the injection site before local anaesthesia, while the control group will receive local anaesthesia without pre-cooling.
Outcome Measures: Pain perception during injection (assessed using a standardized pain scale) and postoperative pain levels (measured at different time intervals).
Significance: The study aims to determine whether pre-cooling with popsicles is an effective, non-invasive, and child-friendly method for pain management in pediatric dental procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.children age 4-10 years
- •frankles behavior rating scale 3 and 4
- •child with first dental visit
- •With no significant medical condition
- •Child undergoing only extraction treatment.
排除标准
- •Treatment other than extraction
- •Frankles behavior rating scale 1 and 2
- •Medically compromised individuals
- •Parents who didnt give consent.
结局指标
主要结局
pain perception
时间窗: Baseline
次要结局
- Anxiety(baseline)
研究者
Harsh Sanjaykumar Baldawa
Saveetha Dental College, SIMATS University