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Clinical Trials/CTRI/2022/01/039273
CTRI/2022/01/039273Not yet recruitingPhase 2

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

jalpa solanki1 site in 1 country98 target enrollmentStarted: October 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
98
Locations
1
Primary Endpoint
to check the anxity and behavior

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Not Applicable

Eligibility Criteria

Ages
6.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

to check the anxity and behavior

Time Frame: 6 MONTHS

Secondary Outcomes

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

Investigators

Sponsor
jalpa solanki
Sponsor Class
Private hospital/clinic

Study Sites (1)

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