Comparative Evaluation of pain perception following topical application of Clove Oil, Betel leaf extract, Lignocaine gels and Ice prior to intraoral injection in children aged 6-10years. - A Randomized Control Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare and evaluate the pain perception following topical application of clove oil, betel leaf extract, lignocaine gels & ice prior to intraoral infilterations.
研究概览
简要总结
Aim: Current study aims to compare and evaluate pain perception following topical application of lignocaine gel, clove-based gel, ice and newly developed betel leaf extract gel during intraoral injection in children.
Materials and method: 60 children aged between 6-10 years who meet inclusion criteria will be divided in four groups.
Topical anesthetic agents (clove oil, betel leaf extract, lignocaine gels and ice) will be applied in respective group for one minute which is followed by administration of lignocaine infiltration using 26-gauge needle. Pain perception will be analysed subjectively by Wong Bakers FACES pain rating scale (WBFPRS) and objectively by Sound, Eye, Motor scale (SEM) scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •A) Children of age group of 6-10 years.
- •B) Children requiring administration of infiltration anesthesia irrespective of treatment.
- •C) Children with Frankl’s behaviour rating 3 and
- •D) Children with good general health (ASA I).
- •E) Children who are willing to participate and whose parents give informed consent.
排除标准
- •A) Medically compromised children.
- •B) Patient with history of anxiety disorder.
- •C) Children or parents not willing to participate.
- •D) Patients with history of allergy to local anesthesia.
- •E) Patients on medication that can alter pain perception.
- •F) Children with active pathology at the administration site.
结局指标
主要结局
To compare and evaluate the pain perception following topical application of clove oil, betel leaf extract, lignocaine gels & ice prior to intraoral infilterations.
时间窗: 60 seconds after the application of comparator agents
次要结局
- To evaluate for any adverse effects following topical application of comparator agent(60 seconds after the application of comparator agents)