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.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Administring local anaesthesia for inferior alveolar nerve block using painless transcodent needle having three edge lancet bevel through starpen anaesthetic device.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Administring local anaesthesia for inferior alveolar nerve block using painless transcodent needle having three edge lancet bevel through starpen anaesthetic device.
时间窗: pain assessment on day 1 and day 15
次要结局
- 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)