NCT00565682已完成4 期
Pain Post Abdominal Laparoscopy Prevention With Arcoxia
Hospital Vozandez0 个研究点目标入组 60 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- To measure the amount of rescue medication (opioid) needed to relief
研究概览
简要总结
To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary acceptance to participate in the study and signed the informed consent form
- •Age older than 18 years old and younger than 70 years
- •Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery
排除标准
- •Age less than 18 years or older than 70 years.
- •Laparoscopic procedures for diagnostic purposes.
- •Current use of anticoagulants.
- •Known hypersensitivity to etoricoxib or its components.
- •History of a CABG or MI (less than 1 year)
- •History of unstable angina (over the past six months).
- •Current inflammatory bowel disease.
- •Uncontrolled hypertension or heart failure
- •Renal dysfunction/impairment (creatinine clearance < 30ml/min)
- •Cirrhosis or severe hepatic dysfunction
- •Any degree of dehydration (mild to severe)
研究组 & 干预措施
A
Experimental
Etoricoxib 120 mg
干预措施: etoricoxib 120 mg (Drug)
结局指标
主要结局
To measure the amount of rescue medication (opioid) needed to relief
时间窗: Every hour after surgery
次要结局
- To determine the overall analgesic effect using the visual analog scale (VAS)(Every hour after surgery)
研究者
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