Comparing the level of pain in Children during giving injection using Special Electronic Device and Needle.

Phase 3

Not yet recruiting

• Conditions: children requiring bilateral local anaesthesia in their dental treatment

• Registration Number: CTRI/2025/05/086337
• Lead Sponsor: Dr. Neha Gajewar

Brief Summary

The study aims to assess and compare pain perception using Starpen with Transcodent needle and Starpen with Conventional needle in children between 5 to 10 years of age undergoing inferior alveolar nerve block procedure.

1. To assess pain perception of 5 to 10 years old child during inferior alveolar nerve block by Starpen with Transcodent needle using Visual Analog Scale (VAS) , Face, Legs, Activity, Cry, Consolability Scale (FLACC) and physiological parameter (pulse rate and SpO2).

2. To assess pain perception of 5 to 10 years old child during inferior alveolar nerve block by Starpen with Conventional needle using Visual Analog Scale (VAS) , Face, Legs, Activity, Cry, Consolability Scale (FLACC) and physiological parameter (pulse rate and SpO2).

3. To compare pain perception of 5 to 10 years old child during inferior alveolar nerve block by Starpen with Transcodent needle and Starpen with conventional needle using Visual Analog Scale (VAS) , Face, Legs, Activity, Cry, Consolability Scale (FLACC) and physiological parameter (pulse rate and SpO2).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-30
• Study Start: 2025-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Children requiring bilateral inferior alveolar nerve block for any dental procedures.
• 2.Children exhibiting a 3 or 4 rating according to Frankl’s behaviour rating scale.
• 3.Children refrained from medication (antibiotics and analgesics) for the previous 48h that could impact their response to local anaesthesia.

Exclusion Criteria

• Children with systemic condition.
• Children with asthma and / or any known allergy of lignocaine.
• Parent who do not give consent for their child to participate in study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Administring local anaesthesia for inferior alveolar nerve block using painless transcodent needle having three edge lancet bevel through starpen anaesthetic device.	pain assessment on day 1 and day 15

Secondary Outcome Measures

Name	Time	Method
there will be no difference in administring local anaesthesia for inferior alveolar nerve block block through conventional needle or painless transcodent needle	pain assessment on day 1 and day 15

Trial Locations

Locations (1)

K. M. Shah Dental College and Hospital; 🇮🇳 Vadodara, GUJARAT, India

K. M. Shah Dental College and Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Neha Gajewar

Principal investigator

07774007208

nehagajewar1@gmail.com