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临床试验/CTRI/2024/02/063133
CTRI/2024/02/063133已完成4 期

To assess reduction in Pain Perception after topical application of Lignocaine gel, Flavored lignocaine gel and Honey in children aged 6–12 years requiring local anaesthesia infiltration for dental treatment: a randomized controlled trial.

Dr Krishna Kajave1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Reduction in pain perception

研究概览

简要总结

The aim of the study will be to evaluate and compare the effectiveness of topical application of lignocaine gel, flavored lignocaine gel and honey at injection site for reducing pain in children aged 6–12 years requiring maxillary local anaesthesia infiltration for dental treatment. Children who fulfil the inclusion and exclusion criteria will be made to sit comfortably on the dental chair and the procedure will be explained to the parent as well as the children. A case history will be recorded so as to have systematic and methodological recording of all the observations and information. Pulse rate will be recorded prior to the administration of local anaesthesia. The site of injection will be wiped with a clean sterile gauze. Topical anaesthetic will be then applied to the site using a sterile cotton tip applicator for 2 minutes. A preloaded syringe of 2% lignocaine with 1:80,000 adrenaline will be used to deliver local anaesthetic at the injection site. Pulse rate will be recorded after the administration of local anaesthetic. Pain perception will be recorded subjectively by the Wong bakers faces pain rating scale and will be done objectively by the sound, eye, body movement scale.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor 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

  • Children between 6-12 years of age.
  • Children visiting dental clinic for the first time.
  • Children who require administration of local anaesthesia infiltration (maxillary) for the dental treatment.

排除标准

  • 未提供

结局指标

主要结局

Reduction in pain perception

时间窗: Reduction in pain perception immediately after injecting local anaesthesia infiltration

次要结局

未报告次要终点

研究者

发起方
Dr Krishna Kajave
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Krishna Kajave

KAHERs KLE VK Institute of Dental Sciences, Belagavi

研究点 (1)

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