跳至主要内容
临床试验/CTRI/2025/03/082187
CTRI/2025/03/082187招募中不适用

Effect of buffered vs non-buffered local anesthetic solution on pain perception and onset of anesthesia in children.

Self College of dental sciences and research centre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月17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
50
试验地点
1
主要终点
Pain perception and time of onset of anesthesia

研究概览

简要总结

Introduction

Dental anxiety and fear of needle injection is one of the most common problems encountered by dental practitioners, especially in the pediatric patient. Several methods are suggested to lower the discomfort of local anesthesia injection during dental procedures. There are some technical advances to lower the pain of injection by alkalization of dental anesthetics prior to injection.

Aim:

This study aims to evaluate the efficacy of pH buffering of local anesthetic drug, on the pain,discomfort and onset of local anesthesia injection during dental procedures.

Children divided randomly in 2 groups- Test group and Control Group

Group 1 – Test group-The test solution -alkalinized 2% lidocaine/ epinephrine 1:100,000 is administered before the dental treatment.

Group 2- Control group- non-alkalinized 2% lidocaine/epinephrine 1:100,000  is administered before the dental treatment.

Pain perception during the administration of local anesthesia, the time of onset and efficacy of analgesia assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

  • patients between 6-10 years of age who had not undergone any prior dental treatment, requiring bilateral IANB and exhibited Frankl behavior rating grade 3 or 4.

排除标准

  • Patients who were allergic to local anesthesia; had medically-compromised condition or, History of dental treatment.

结局指标

主要结局

Pain perception and time of onset of anesthesia

时间窗: Same day , 1 week

次要结局

  • efficacy of analgesia(same day, after 1 week)

研究者

发起方
Self College of dental sciences and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Harsha Kewlani

College of Dental sciences and research centre, Bopal

研究点 (1)

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