Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The patients' total amount of morphine requirement in the first 24 hour.
研究概览
简要总结
The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after TURP.
The research hypothesis:
There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.
详细描述
Postoperative pain is still a significant problem for surgical patients. Conventional use of narcotics for postoperative pain relief is not without serious side effects such as respiratory depression and sedation.There are other alternatives for postoperative analgesia as NSAIDs especially COX2-inhibitors. For some specific operation such as TURP which Foley's catheter needed to be retained for a few days,urinary anti spasmodics may help the patients to be more comfortable.
Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient ASA physical status I-III.
- •Scheduled for an elective TURP.
- •Body weight > or = 50 kg
- •Can operate a patient-controlled analgesia (PCA) device.
排除标准
- •History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
- •Known hypersensitivity to morphine.
- •History of hepatic dysfunction.
- •Creatinine clearance < 30ml/min.
- •History of bleeding tendency.
- •History of gastrointestinal bleeding or active peptic ulcer.
- •Known case of inflammatory bowel disease.
- •Patient with severe heart failure.
- •History of coronary artery disease or cerebrovascular disease.
研究组 & 干预措施
1
1=placebo
干预措施: placebo (Drug)
2
2= etoricoxib
干预措施: etoricoxib (Drug)
3
3=falvoxate
干预措施: flavoxate (Drug)
4
etoricoxib and flavoxate
干预措施: etoricoxib, flavoxate (Drug)
结局指标
主要结局
The patients' total amount of morphine requirement in the first 24 hour.
时间窗: 24 hour
次要结局
未报告次要终点