Effectiveness of Laser Photobiomodulation Therapy in Reducing Child Pain During Local Anesthesia Injection (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Heart Rate
研究概览
简要总结
This study aimed to evaluate the impact of laser photobiomodulation therapy used as pre-anesthetic technique to reduce child pain during local anesthesia administration
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
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the written informed consent form by parents/guardian.
- •Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
- •Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
- •Lack of history of allergy to the materials used for anesthesia and sulfite
- •Children free of any systemic disease or special health care needs (ASA 1)
排除标准
- •Children who receive any analgesic drugs at least 24 hours before treatment.
- •Any inflammation or lesion in the injection site
- •Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
- •Child coming for emergency treatment of pain
研究组 & 干预措施
Photobiomodulation
干预措施: Photobiomodulation (Device)
Topical anesthesia
干预措施: Benzocaine Gel (Drug)
结局指标
主要结局
Heart Rate
时间窗: during local anesthesia administration
A brief demonstration of the pulse oximeter will be performed, and the patient will be instructed to remain still and avoid hand movement in order to obtain accurate readings. The pulse oximeter will be placed on the patient's index finger to measure the baseline heart rate (prior to administering the LA), and another measurement will be taken during the LA administration. Heart rate will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
Pain Reaction
时间窗: during local anesthesia administration
The Sound, Eye, Motor (SEM) Scale will be used to assess pain. It encompasses the following parameters: (1) Sound, (2) Eye and (3) Motor. The sounds, eye symptoms and body movements of each child will be independently evaluated by a blind impartial observer using the recorded video tapes. The slightest manifestation of the patient's sound, eyes, or motion is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. The SEM score will be calculated by adding the three parameter grades.
Perceived Pain
时间窗: immediately after local anesthesia administration
To subjectively record pain during LA injection, a modified face scale will be used. It comprises three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively. Each child will be taught before injection how to use the scale by modelling and then asking each participant to recall the last time she or he felt something painful and select the facial expression that best represented his or her experience of discomfort.
次要结局
未报告次要终点
研究者
Aliaa Hamouda
Assistant Lecturer of Pediatric Dentistry
Alexandria University