Comparative evaluation of the effect of Modified V-Pen and Vibracool device on pain perception during Inferior alveolar nerve block procedure in children : A Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
The study is designed as a Randomized controlled trial (RCT) to evaluate the effectiveness of vibratory-cooling distraction techniques in reducing pain and improving behavior during Inferior alveolar nerve block (IANB) administration in children.
A total sample size of 90 children aged 5-10 years with no prior experience of local anesthesia will be included. Participants will be randomly allocated into 3 groups using a lottery method with 30 children in each group.
Group 1 : Extraoral Vibracool technique- where a vibratory cooling device will be placed extraorally on the mandibular ramus near the injection site prior and during IANB.
Group 2 : Intraoral cooled V-Pen technique- where a vibrating intraoral device with a cooled tip will be applied close to the injection site prior and during the procedure.
Group 3 - where IANB will be administered using the conventional technique.
All injections will be performed by a single operator using 2 % lignocaine with 1: 80000 adrenaline, following the standard IANB technique. Children will be allowed to rest in the dental chair for 5 minutes prior to the procedure and the entire procedure will be video recorded discreetly without the child’s awareness.
The outcomes assessed will include anxiety levels using the RMS Pictorial Scale, Pain perception using the Modified Wong- Baker faces pain rating scale , Child behavior using the HOUPT Behavior rating scale evaluated from video recordings by two blinded observers and and physiological parameters (pulse rate and oxygen saturation) to assess stress response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •No prior experience of dental anesthesia.
- •Indication of at least one dental procedure requiring Inferior Alveolar Nerve Block.
排除标准
- •Children who had a prior medical history of hospitalization or surgery, chronic illnesses, neuro behavioural disorders, local anaesthetic allergies, or infection at the site of injection were excluded.
- •History of fainting during injection
- •Children with special care needs.
- •Patients with painful dental experiences in the past and unco-operative children.
研究者
Dr Lakshmi Mounica Yerubandi
GITAM Dental College and Hospital