Evaluation of Pain Perception during Local Anesthetic Procedure using Electronic Anesthetic Device with Transcodent needle in 5-10 years old Children: A Randomized Clinical Study.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Administring local anaesthesia for inferior alveolar nerve block using painless transcodent needle having three edge lancet bevel through starpen anaesthetic device.
Study Overview
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.
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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).
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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).
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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).
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Administring local anaesthesia for inferior alveolar nerve block using painless transcodent needle having three edge lancet bevel through starpen anaesthetic device.
Time Frame: pain assessment on day 1 and day 15
Secondary Outcomes
- 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)