The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 75
- 主要终点
- Contramal consumption
研究概览
简要总结
Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.
详细描述
Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol 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, Investigator)
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery
排除标准
- •were known allergies to any of the drugs used in this study
- •peptic ulcer disease
- •hepatic and renal dysfunction,
- •emergency surgery
- •inability to provide informed consent
研究组 & 干预措施
550 mg naproxen sodium and 30mg codeine
Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
干预措施: 550 mg naproxen sodium and 30mg codeine (Drug)
300 mg paracetamol and 30 mg codeine
Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
干预措施: 300 mg paracetamol and 30 mg codeine (Drug)
Placebo
Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
干预措施: placebo tablet (Drug)
结局指标
主要结局
Contramal consumption
时间窗: Postoperative 24 hour
To assess contramal consumption
次要结局
- Side effects(postoperative 24 hour)
- Pain intensity(postoperative 24 hour)
研究者
Reyhan Polat
Medical Doctor
Diskapi Yildirim Beyazit Education and Research Hospital