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临床试验/CTRI/2025/12/098531
CTRI/2025/12/098531尚未招募不适用

"Comparative Evaluation of Pain Perception Using Midazolam and Lignocaine as Topical Agents Prior To IANB in Children Undergoing Pulpectomy "

Department of Pediatric and Preventive Dentistry1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
pain perception

研究概览

简要总结

Aim: To evaluate pain perception by using Lignocaine and Midazolam as topical anaesthetic agents prior to inferior alveolar nerve block in 3–11 year old children undergoing pulpectomy procedures

Introduction: Inferior alveolar nerve block (IANB) is one of the most commonly used local anaesthesia techniques in paediatric dentistry but remains highly anxiety-provoking and painful for children. Conventional topical anaesthetics, primarily Lignocaine, provide only partial relief. Midazolam, a benzodiazepine with sedative and anxiolytic properties, has recently been explored for its potential topical anaesthetic effect on oral mucosa.

Methodology: A randomized controlled clinical trial was conducted on 80 children aged between 3–11 years requiring pulpectomy[Ma1]  in mandibular primary molars. Participants were randomly assigned into two groups: Group A ( Lignocaine spray ) and Group B (Midazolam spray ) applied for a minute before IANB. Pain perception during injection was assessed using the SEM scale. The time until the area was anesthetized was also measured in minutes.

Results: Children in the Midazolam group demonstrated significantly lower pain scores on SEM scale when compared with Lignocaine group. Also there were no post-anaesthetic complications in any of the children.

Conclusion: Thus, topical Midazolam demonstrated superior efficacy compared to Lignocaine in reducing pain and anxiety during IANB in young children. Its dual action as a topical anaesthetic and anxiolytic makes it a promising adjunct for paediatric dentistry.


[Ma1]

研究设计

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

入排标准

年龄范围
3.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • healthy, co-operative children aged between 3-11 years,who needed pulpectomy in lower jaw.

排除标准

  • unco-operative children special children children wih swelling.

结局指标

主要结局

pain perception

时间窗: pain perception | anesthesia onset and duration at 1 hr interval and 1 day follow up

anesthesia onset and duration at 1 hr interval and 1 day follow up

时间窗: pain perception | anesthesia onset and duration at 1 hr interval and 1 day follow up

次要结局

未报告次要终点

研究者

发起方
Department of Pediatric and Preventive Dentistry
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Siddhi Lunawat

Pacific Dental College And Hospital, Debari

研究点 (1)

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