A comparative randomized double blind study comparing effect of 0.5% dilution of propofol ( MCT/LCT) with 0.5 % dilution of propofol (LCT) on Injection Pain During Induction of anaesthesia in paediatric patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the effect of 0.5% dilution of propofol MCT/LCT with propofol LCT for injection pain during induction of general anaesthesia (GA) in paediatric patients.
研究概览
简要总结
Propofol is the most frequently used IV anaesthetic today. Propofol, when used for induction of anaesthesia in brief procedures, results in a significantly quicker recovery and an earlier return of psychomotor function compared with other induction agents. Induction ofanaesthesia is associated with several side effects with pain during intravenous injection being major among them. In view of the above consideration, this clinical study was performed to assess the comparative effects of 0.5% dilution of propofol MCT/LCT with 0.5% dilution of propofol LCT on injection pain.
A hundred ASA physical status I & II patients ,aged 6-12 years, both male and female posted for various elective surgeries under general anaesthesia were studied.
The patients were divided into two groups of fifty each:
Group LCT &Group MCT/ LCT (N = 50 ), according to the computer generated list.
Group LCT received 0.5% dilution of propofol (LCT) at 2mg/kg
Group MCT/ LCT received 0.5% dilution of propofol (MCT LCT) at 2mg/kg
Pain on propofol injection was assessed using Mc Crirrick and Hunter scale of evaluation of propofol injection pain.The patients in both groups were comparable with respect to demographic and hemodynamic parameters.Our study showed that 66% of group MCT/LCT and 12% of group LCT had no pain at all. While 8% in group MCT/LCT and 4% in group LCT had mild pain. The patients who experienced moderate pain were 18% in group MCT/LCT and 54% in group LCT,while only 8% had severe pain in group MCT/LCT compared to 30% in group LCT The difference in pain on injection was significantly less in group 0.5% MCT/LCT compared to group 0.5% LCT with P value of 0.0000 being highly significant. Hence we can conclude that using 0.5% dilution of propofol MCT/LCT has significantly reduced the incidence,intensity and severity of pain on propofol injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 and ASA 2 patients.
排除标准
- •ASA 3 and 4 patients co existing systemic disease contra indication to propofol.
结局指标
主要结局
To compare the effect of 0.5% dilution of propofol MCT/LCT with propofol LCT for injection pain during induction of general anaesthesia (GA) in paediatric patients.
时间窗: 15 seconds, 30 seconds and 1 minute intervals.
次要结局
- To compare the effect of 0.5 % dilution of propofol MCT/LCT with propofol LCT on haemodynamic changes during induction of GA in both the groups.(15 seconds, 30 seconds and further at 1 minute intervals upto 5 minutes after induction)