Non-steroidal Anti-inflammatory Drugs in Pleurodesis Surgery for Pneumothorax
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- duration of pleural drainage
研究概览
简要总结
Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended in a multimodal pain management to reduce pain intensity and to spare opioid use. However, there is a controversy in its use in pleurodesis surgery as it could block the process of pleurodesis in surgical pneumothorax. In addition, NSAIDs could increase the risk of pneumothorax recurrence.
The investigators hypothesized that NSAIDs are safe during pleurodesis with a better pain management without increasing the risk of pneumothorax reccurence.
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
- Double (Participant, Care Provider)
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
- •Age≥18-year-old
- •pneumothorax with an indication of pleurodesis
- •with or without minimal lung resection
- •via thoracotomy or thoracoscopy
排除标准
- •Minor patient
- •Pregnant, parturient or breast-feeding patient
- •Severe polytrauma (associated with the presence of a Vittel criterion)
- •Purulent pleurisy
- •Hemopneumothorax
- •Lactose hyper sensibility
- •Contraindications to NSAID
- •Contraindications to tramadol
- •Contraindications to paracetamol
- •Curative anticoagulation
- •Patients under guardians or deprived of their liberty
- •Patient refusal
研究组 & 干预措施
Interventional group
one intravenous dose of ketoprofen 100 mg followed by 5 doses every 12 h of ketoprofen LP 100 mg (a total regimen of 6 doses of ketoprofen every 12 h for 72h)
干预措施: pleurodesis procedures (Procedure)
Interventional group
one intravenous dose of ketoprofen 100 mg followed by 5 doses every 12 h of ketoprofen LP 100 mg (a total regimen of 6 doses of ketoprofen every 12 h for 72h)
干预措施: KETOPROFEN(RP19583) (Drug)
Control group
placebo of ketoprofen with the schema of administration consisting in the administration of one intravenous dose of 100 ml of NaCl 0.9% following 6 oral intakes of a placebo pill every 12h (a total regimen of 6 doses of placebo of NSAID every 12 h for 72h)
干预措施: pleurodesis procedures (Procedure)
Control group
placebo of ketoprofen with the schema of administration consisting in the administration of one intravenous dose of 100 ml of NaCl 0.9% following 6 oral intakes of a placebo pill every 12h (a total regimen of 6 doses of placebo of NSAID every 12 h for 72h)
干预措施: Placebo (Drug)
结局指标
主要结局
duration of pleural drainage
时间窗: from the time of orotracheal extubation to the time of pleural tube remove
duration of pleural drainage from the time of orotracheal extubation to the time of pleural tube remove recorded in hours.
次要结局
- postoperative pain(at 72 hours)
- cumulative postoperative opioid equivalent dose(at 72 hours)
- Postoperative pneumonia occurence(From enrollment to the end of hospital stay, up to 6 months)
- Length of hospital stay(From enrollment to the end of hospital stay, up to 6 months)
- homolateral or contralateral recurrence in spontaneous pneumothorax(at 12 months)