跳至主要内容
临床试验/CTRI/2022/01/039273
CTRI/2022/01/039273尚未招募2 期

“EVALUATION OF BEHAVIOR AND ANXIETY IN CHILDREN DURING LOCAL ANESTHESIA ADMINISTRATION USING CONVENTIONAL SYRINGE VS CUSTOM MADE ECONOMIC SLEEVE: A CLINICAL STUDYâ€

jalpa solanki1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
98
试验地点
1
主要终点
to check the anxity and behavior

研究概览

简要总结

Before starting any treatment which required local anesthesia injection, 15% topical anesthetic spray (Lidocaine Topical Aerosol USP nummit) (Indian pharmaceutical combine association limited) administration at the injection site. And baseline pulse rate will be noted using a finger pulse oximeter. After that administration of local anesthesia in group 1: using conventional syringe and group 2: using custom made economical syringe during this procedure the co-investigator record   the pulse rate.

During the local anesthesia administration (2% Lignocaine hydrochloride & Adrenaline bitartrate) ((Indian pharmaceutical combine association limited)), co-investigator records video in Redmi 8A mobile with Resolution 1030p at 30fps. to grade the child’s behavior using the Faces, Legs, Arms, Crying, Consolability (FLACC) behavior pain scale

Inclusion:

 1)    Children aged between 6-11 year olds who required local anesthesia during any dental procedure.

2)    Those children are having positive and definitely positive frankl behavior.

                               |Exclusion:

 1)    Medically compromise children.

2)    Parents who refuse written consent.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

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 aged between 6-11 years old who required local anesthesia during any dental procedure.
  • •Those children are having positive and definitely positive Frankl behavior.

排除标准

  • •Medically compromise children.
  • •Parents who refuse written consent.

结局指标

主要结局

to check the anxity and behavior

时间窗: 6 MONTHS

次要结局

  • coparition between behavior and anxity using conventinal syringe vs costim made sleev syringe(6months)

研究者

发起方
jalpa solanki
申办方类型
Private hospital/clinic

研究点 (1)

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