The Effect of a Sugar-free-flavored-sweet-tasting-solution on Pain Associated With Dental Injections in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Self-reported pain using faces pain scale-revised (FPS-r)
研究概览
简要总结
The goal of this clinical trial is to learn whether applying a sugar-free flavored sweet solution (SFSS) before local anesthesia helps reduce injection pain in children.
The main question it aims to answer is:
Does SFSS reduce pain during dental local anesthesia compared to a placebo (plain water)? Researchers will compare the use of SFSS and a placebo to see which results in lower pain scores.
Participants will:
Receive SFSS or placebo before local anesthesia during two dental visits Have their pain measured using self-reported and observational pain scales Have their heart rate monitored during the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who are 6-12 years of age.
- •Children classified as ASA1 according to the American Society of Anesthesiologists.
- •Children who have positive (Class III) or definitely positive (Class IV) behavior during preoperative behavioral assessments according to the Frankl Scale.
- •Children who required bilateral local anesthesia infiltration injections on primary or permanent teeth either in the maxilla or mandible for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
- •Children with positive consent forms (signed and approved by their parents/ legal guardians) and attended the appointment.
排除标准
- •Children who had a history of unpleasant experiences in dental settings.
- •Children who had a history of unpleasant experience with local anesthesia injection.
- •The presence of medically or developmentally compromising conditions.
研究组 & 干预措施
Sugar-free-flavored sweet tasting solution Group
干预措施: Sugar-free-flavored sweet tasting solution (Other)
Placebo Group
干预措施: Placebo (sterile-water) (Other)
结局指标
主要结局
Self-reported pain using faces pain scale-revised (FPS-r)
时间窗: Immediately after local anesthetic injection
Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.
Self-reported pain using faces pain scale-revised (FPS-r)
时间窗: Immediately after local anesthetic injection
Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
时间窗: During administration of the local anesthetic injection
Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.
Physiological-Heart Rate
时间窗: Baseline and During Injection
Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain
次要结局
未报告次要终点
研究者
Lamis D. Rajab
Prof
University of Jordan