Comparison of efficacy of Photobiomodulation (PBM) and topical anesthetic spray in reducing the injection pain in children of age 6-12 years.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- subjective pain assessment using wong bakers pain rating scale
研究概览
简要总结
The study aimed to compare the efficacy of PBM with LA spray in reducing injection pain in children during administration of local anesthesia. Children of age 6-12 years old will be screened attending the outpatient department of Pedodontics and Preventive Dentistry, Vishnu dental college. Details of the study will be explained to the parents and written informed consent will be obtained. Children requiring local anesthesia administration for extractions will be taken and will be randomly allocated into 3 groups . Group – I (Topical anesthetic spray with sham laser), group – 2 (PBM 810nm, 0.6W, 40 sec, CW mode) and group – III (810nm, 0.6W, 3minutes, CW), with a pause of 5 seconds/ 10 seconds for every 30 seconds. Area to be anesthetized will be dried in all the three groups, followed by topical spray application for 1minute in group I, PBM of 810nm, 0.6W, 40 sec, CW will be applied in group II and PBM of 810nm, 0.6W, 3 min, CW with a pause of 5 seconds/ 10 seconds for every 30 seconds will be applied in group III.Administration of local anesthesia infiltration using 24 gauge needle followed by subjective and objective pain assessments with Wong Baker’s Pain rating scale and Sound Eye Motor scale respectively. Data obtained will be subjected to the statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children of age 6- 12 years requiring local anesthesia administration for extractions.
- •2.Children without medical history of systemic diseases 3.Patients who have no previous experience of local anesthesia.
- •• Patients not allergic to local anaesthetics.
排除标准
- •1.Children who were under any medication (pain killer/ NSAIDS/ Opioids) that might affect anaesthetic assessment.
- •2.Children who need block for local administration.
- •3.Children with special health care needs.
结局指标
主要结局
subjective pain assessment using wong bakers pain rating scale
时间窗: single visit-baseline
objective assessment using Sound eye motor scale
时间窗: single visit-baseline
次要结局
未报告次要终点
研究者
Bollepalli Bhavana
Vishnu Dental College
