NCT00763685终止4 期
Double-Blind, Randomized, Placebo -Controlled Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery
East Tallinn Central Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年6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
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain scale
研究概览
简要总结
Primary Hypothesis:
- The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater than that of placebo in the treatment of postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Type of gynaecologic surgery:
- •diagnostic laparoscopy
- •sterilization
- •removal of ovarial cyst
- •chromopertubation
- •laparoscopic myomectomy
- •laparoscopic fenestration of ovaria
- •laparoscopic adhesiolysis
- •Age 18-50 years.
- •Evaluated risk of anaesthetic procedure according to ASA (American Society of Anaesthesiologist) classification: ASA I or II.
- •Patients agreed to participate in the study and signed the informed consent.
排除标准
- •ASA III or more
- •Emergency surgery
- •Major laparoscopic surgery i.e. hysterectomy
- •Duration of surgery more than 90 minutes
- •Chronic pain
- •History of hypersensitivity to the active substance or to any of the excipients of study drug (Paracetamol or Etoricoxib)
- •Active peptic ulceration or active gastro-intestinal (GI) bleeding.
- •Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
- •Pregnancy and lactation
- •Severe hepatic dysfunction (serum albumin < 25 g/l or Child-Pugh score ≥ 10).
- •Estimated renal creatinine clearance < 30 mL/min.
- •Children and adolescents under 16 years of age.
- •Inflammatory bowel disease.
- •Congestive heart failure (NYHA II-IV).
- •Patients with hypertension whose blood pressure has not been adequately controlled.
- •Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, unstable angina.
- •Patient has undergone coronary artery bypass graft surgery, angioplasty, or had myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.
- •History of drug abuse.
研究组 & 干预措施
etoricoxib 120 mg
Active Comparator
active control
干预措施: etoricoxib (Drug)
2
Placebo Comparator
Placebo
干预措施: etoricoxib (Drug)
3
Active Comparator
Paracetamol 1 g and etoricoxib 120 mg
干预措施: etoricoxib (Drug)
结局指标
主要结局
Pain scale
时间窗: 24 hours
次要结局
- Vomiting(24 hours)
研究者
Tiina Arumagi
anaesthesiologist
East Tallinn Central Hospital
研究点 (1)
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