Prevention of pain on propofol injection in children using the Buzzy device versus pre injection with preservative free 2 percent Lignocaine, a randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Assess the pain response to injection of propofol while using Buzzy device and compare it to the pain response seen with propofol injection when pre injection of preservative free 2% Lignocaine is given
研究概览
简要总结
This study is a Double Blinded Randomised Controlled study which will be conducted inRangadore Memorial Hospital, Bengaluru, Karnataka. It assesses prevention of propofol injection pain in children.
Propofol is a commonly used intravenous anesthetic for induction of general anesthesia and causes pain on injection.
Children in the age group of 8 months to 10 years, belonging to ASA Physical statuses 1 and 2, undergoing various surgical procedures under General Anesthesia are included in this study and are randomly allocated to two different intervention groups.
One group of the children in the study would receive propofol injection with Buzzy device.
The other group of children in the study would receive a preinjection of preservative free 2% Lignocaine intravenously, prior to injection of propofol.
Pain scores during propofol injection and hemodynamic parameters would be recorded in all patients.
The Primary objective is to assess the pain response to injection of propofol and compare the pain responses between the two intervention groups.
The Secondary objective is to assess change in heart rate to propofol injection while using Buzzy device and compare it with the change in heart rate to propofol injection when preinjection of preservative free 2% Lignocaine administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Month(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 8 months to 10 years, males and females, belonging to ASA (American Society of Anesthesiologists) Physical status 1 and 2, undergoing surgery under General Anesthesia.
排除标准
- •The following are the exclusion criteria.
- •Crying children despite use of intravenous anxiolytic injection, shock, hypotension, bradycardia, allergy to egg lecithin, children on preoperative analgesics and children who need sevoflurane based inhalational induction for intravenous cannulation.
结局指标
主要结局
Assess the pain response to injection of propofol while using Buzzy device and compare it to the pain response seen with propofol injection when pre injection of preservative free 2% Lignocaine is given
时间窗: Compare the Pain Scores between the two groups
次要结局
- Assess change in heart rate to propofol injection while using Buzzy device & compare it with the change in heart rate to propofol injection when preinjection of preservative free 2 percent Lignocaine administered.(Compare the heart rate responses between the two groups)
研究者
Dr Kavya KG
Rangadore Memorial Hospital