Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- NSAIDs reduce postoperative at rest at 24 hours from the end of surgery
研究概览
简要总结
Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
- •under cardiopulmonary bypass
- •Affiliation to the French national healthcare system
- •Written consent obtained
排除标准
- •weight<50 kg
- •chronic use of NSAID
- •mini-invasive surgery
- •NSAID contraindication
- •NSAID allergy
- •Nefopam contraindication
- •Paracetamol contraindication
- •Tramadol contraindication
- •Urgent surgery
- •Endocarditis
- •Immunosuppressive drug
- •HIV infection with CD4<200 mm3
- •Organ transplantation
- •Stage 4 or 5 chronic kidney disease
- •Gastro duodenal ulcer
- •Pregnancy
- •Depression
- •Auto immune disease
研究组 & 干预措施
Ketoprofen
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
干预措施: pain management (Drug)
Ketoprofen
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
干预措施: ketoprofen (Drug)
Placebo
Placebo twice a day, during 48 h after surgery, intravenous administration
干预措施: pain management (Drug)
Placebo
Placebo twice a day, during 48 h after surgery, intravenous administration
干预措施: PLacebo (Drug)
结局指标
主要结局
NSAIDs reduce postoperative at rest at 24 hours from the end of surgery
时间窗: at 24 hours
Pain intensity will be assessed at rest at 24 hours from the end surgery using the numerous rating scale (NRS) graded from 1 (no pain) to 10 (high pain intensity)
reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery
时间窗: at 24 hours
Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy
次要结局
- Change in pain trajectory during the first 7 days after cardiac surgery(7 days)
- Change in cumulative opioid within 48 hours after surgery(48 hours)
- Change in pulmonary postoperative complications within 7 days after surgery(7 days)