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临床试验/CTRI/2024/11/076932
CTRI/2024/11/076932招募中不适用

Comparison of efficacy of Photobiomodulation (PBM) and topical anesthetic spray in reducing the injection pain in children of age 6-12 years.

Dr Bollepalli Bhavana1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年11月27日最近更新:

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

发起方
Dr Bollepalli Bhavana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bollepalli Bhavana

Vishnu Dental College

研究点 (1)

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