Comparative evaluation of Clove-Chamomile gel Vs Lignocaine gel as Topical Anaesthetic Prior to Local Anaesthesia in Children: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain perception during local anaesthesia administration, assessed using the Sound-Eye-Motor (SEM) scale (objective) and the Oucher pain scale (subjective).
研究概览
简要总结
This study will be conducted on 52 healthy children aged 8 to 12 years requiring local anaesthesia for dental procedures. The children will be randomly divided into two groups with 26 in each group. Group 1 will receive Clove-Chamomile gel and Group 2 will receive 2 percent Lignocaine gel applied topically on the oral mucosa for one minute before local anaesthesia administration. Pain perception will be assessed using the Sound Eye Motor scale during injection and the Oucher pain scale after injection. Pulse rate will also be recorded using a pulse oximeter before, during, and after the procedure to evaluate physiological 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
- None
入排标准
- 年龄范围
- 8.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •8-12 years old children Children who are willing to participate in the study.
- •Children requiring LA for dental procedures Children with no cognitive disorders.
排除标准
- •Special health care need Children Recent trauma to oral tissues Children with a history of hypersensitivity reactions to any components present in the anaesthetic agents.
结局指标
主要结局
Pain perception during local anaesthesia administration, assessed using the Sound-Eye-Motor (SEM) scale (objective) and the Oucher pain scale (subjective).
时间窗: Pain perception is measured | During LA administration by SEM scale (objective) and | Immediately after LA administration by Oucher pain scale (subjective) | Time points: During LA administration (SEM); Immediately after LA administration (within 1 minute) (Oucher).
次要结局
- Physiological response measured by pulse rate recorded with a pulse oximeter before, during, & after local anaesthesia administration.(Pulse rate (physiological parameter) is measured)
研究者
Ganganapalli Reddy Sravya
Narayana Dental College and Hospital, Nellore