Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain and Contramal Consumption After a Lumbar Disk Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 75
- 主要终点
- Pain intensity, contramal consumption
研究概览
简要总结
Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour after a lumbar disk surgery.
详细描述
Patients were treated using patient-controlled analgesia with contramal for 24 hours after a lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein or isotonic saline (placebo).
The primary endpoint was pain intensity measured by the visual analogue scale, and secondary endpoints were contramal consumption and related side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists 1 or 2 status patients scheduled for elective lumbar disk surgery under general anesthesia
排除标准
- •Patients, known allergies to any of the drugs used in this study
- •eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to provide informed consent (eg, mental disorders)
研究组 & 干预措施
Naproxen sodium codein
Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
干预措施: naproxen sodium codein (Drug)
Paracetamol codein
Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
干预措施: paracetamol codein (Drug)
Placebo tablet
Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity, contramal consumption
时间窗: Postoperative 24 hour
次要结局
- side effects, nausa, vomiting(postoperative 24 hour)
研究者
Reyhan Polat
Medical Doctor
Diskapi Yildirim Beyazit Education and Research Hospital