The Effect of Pregabalin on Pain of Propofol Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Propofol injection pain
研究概览
简要总结
Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.
详细描述
In a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient underwent elective dental surgery.
排除标准
- •Patient with a history of adverse response to lidocaine or pregabalin,
- •Patient with cardiovascular or respiratory disease,
- •Patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.
研究组 & 干预措施
Group L
Lidocaine 40mg was given intravenously before injection of propofol
干预措施: Lidocaine (Drug)
Group L
Lidocaine 40mg was given intravenously before injection of propofol
干预措施: propofol (Drug)
Group LP
Pregabalin 75 mg was given orally 2 hour before surgery
干预措施: Pregabalin (Drug)
Group LP
Pregabalin 75 mg was given orally 2 hour before surgery
干预措施: propofol (Drug)
Group HP
Pregabalin 150 mg was given orally 2 hour before surgery
干预措施: Pregabalin (Drug)
Group HP
Pregabalin 150 mg was given orally 2 hour before surgery
干预措施: propofol (Drug)
结局指标
主要结局
Propofol injection pain
时间窗: 10 seconds after injection of propofol
Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
次要结局
未报告次要终点
研究者
Younghoon Jeon
Professor
Kyungpook National University Hospital