“check the behaviour and anxiety in chlidren during local anesthesia administration by using conventional syringe and costum made economic sleev syringe a clinical trial

Phase 2

Not yet recruiting

• Conditions: VOLUNTEERS REQURED ANESTHESIA FOR THE DENTAL PROCEDURE

• Registration Number: CTRI/2022/01/039273
• Lead Sponsor: jalpa solanki

Brief Summary

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|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

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|**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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-01
• Study Start: 2022-10-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to check the anxity and behavior	6 MONTHS

Secondary Outcome Measures

Name	Time	Method
coparition between behavior and anxity using conventinal syringe vs costim made sleev syringe	6months

Trial Locations

Locations (1)

college of dental sciences hospital; 🇮🇳 Bhavnagar, GUJARAT, India

college of dental sciences hospital

🇮🇳Bhavnagar, GUJARAT, India

jalpa solanki

Principal investigator

6354509864

jalpasolanki2413@gmail.com