Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation : Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Fentanyl consumption by patient-controlled analgesia
研究概览
简要总结
The investigators examined the efficacy of nefopam in patients undergoing kidney transplantation.
详细描述
Drug combination are frequently used to relieve postoperative pain. Nefopam can inhibit serotonin, dopamine, and norepinephrine reuptake through central mechanisms. Several studies have demonstrated analgesic efficacy of nefopam in the postoperative period. The purpose of this study is to ascertain the analgesic effect and tolerance of intravenous nefopam in combination with fentanyl based patient-controlled analgesia after kidney transplantation.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective living donor kidney transplantation
排除标准
- •pre-operative tachycardia (> 100bpm)
- •liver dysfunction
- •severe cardiac disease
- •body mass index ≥ 30 kg/m2
- •drug allergy
研究组 & 干预措施
Control
干预措施: Normal saline (Drug)
Nefopam
干预措施: Nefopam (Drug)
结局指标
主要结局
Fentanyl consumption by patient-controlled analgesia
时间窗: 48 hours
Numerical rating score of pain
时间窗: 48 hours
次要结局
- The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia)(48 hours)
- Early postoperative graft function(until discharge)
研究者
So Yeon Kim
Clinical assistant professor
Severance Hospital