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临床试验/CTRI/2025/07/091768
CTRI/2025/07/091768尚未招募4 期

Comparative evaluation of efficacy of lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block in children aged 6-10 years : A randomized controlled trial.

Ranjeet Deshmukh Dental College and Research Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate and compare pain perception of children aged 6-10 years by using lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block via Wong Bakers FACES Scale and Sound Eye Motor Scale.

研究概览

简要总结

This study aim to evaluate and compare pain perception of children aged 6-10 years by using lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block via Wong Bakers FACESScale and Sound Eye Motor Scale.Also to evaluate the acceptance of lidocaine ice button amongst children.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children indicated for dental procedure requiring a greater palatine nerve block.
  • Children who exhibited Frankl’s behaviour rating three or four.

排除标准

  • Active infection at the site of injection History of hospitalization/ surgery and those with chronic illness Children with known history to allergy to any topical or local anaesthetic agent.

结局指标

主要结局

To evaluate and compare pain perception of children aged 6-10 years by using lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block via Wong Bakers FACES Scale and Sound Eye Motor Scale.

时间窗: baseline, after 5 minutes

次要结局

  • To evaluate the acceptance of lidocaine ice button in children of aged 6-10 years.(immediately after procedure)

研究者

发起方
Ranjeet Deshmukh Dental College and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shruti Dawale

Ranjeet Deshmukh Dental College and Research Centre

研究点 (1)

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