跳至主要内容
临床试验/CTRI/2025/09/095420
CTRI/2025/09/095420尚未招募不适用

Optimizing Palatal Anesthesia in Children: EMLA Cream with Different Drug Delivery Systems

PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2027年10月4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
36
试验地点
1
主要终点
Pain perception during palatal anesthesia measured by:

研究概览

简要总结

The study titled “Optimizing Palatal Anesthesia in Children: EMLA Cream with Different Drug Delivery Systems” aims to improve pain control during pediatric dental procedures. Since conventional topical anesthetics are less effective on the keratinized palatal mucosa, EMLA cream is explored for its ability to enhance anesthesia. The trial involves 36 children randomly divided into three groups: EMLA alone, EMLA with microneedle patches, and EMLA with propylene glycol. Pain perception will be assessed at two points—during palatal probing and tooth extraction—using the Wong-Baker Faces Pain Scale and FLACC scale. The study seeks to determine which drug delivery method provides the most effective and comfortable palatal anesthesia in children.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
6.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 6-14 years.
  • Upper primary teeth indicated for extraction.
  • Not received any pain medication in last 3 hours before the procedure.
  • Never had a negative dental experience.

排除标准

  • Medically compromised and mentally challenged patients.
  • Allergic to anesthetic drugs.

结局指标

主要结局

Pain perception during palatal anesthesia measured by:

时间窗: 4 weeks

Wong-Baker Faces Pain Scale

时间窗: 4 weeks

FLACC (Face, Legs, Activity, Cry, Consolability) Scale

时间窗: 4 weeks

at two stages:

时间窗: 4 weeks

During palatal probing

时间窗: 4 weeks

During the tooth extraction procedure

时间窗: 4 weeks

次要结局

  • Comparative efficacy of the three delivery methods (EMLA alone, EMLA with microneedle patches, EMLA with propylene glycol) in reducing pain.

研究者

发起方
PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR PRAGYA

PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHOPAL

研究点 (1)

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