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

Launched by EAST TALLINN CENTRAL HOSPITAL · Sep 30, 2008

Keywords

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 1. Type of gynaecologic surgery:
• • diagnostic laparoscopy
• • sterilization
• • removal of ovarial cyst
• • chromopertubation
• • laparoscopic myomectomy
• • laparoscopic fenestration of ovaria
• • laparoscopic adhesiolysis
• • 2. Age 18-50 years.
• • 3. Evaluated risk of anaesthetic procedure according to ASA (American Society of Anaesthesiologist) classification: ASA I or II.
• • 4. Patients agreed to participate in the study and signed the informed consent.
• Exclusion Criteria:
• • 1. ASA III or more
• • 2. Emergency surgery
• • 3. Major laparoscopic surgery i.e. hysterectomy
• • 4. Duration of surgery more than 90 minutes
• • 5. Chronic pain
• • 6. History of hypersensitivity to the active substance or to any of the excipients of study drug (Paracetamol or Etoricoxib)
• • 7. Active peptic ulceration or active gastro-intestinal (GI) bleeding.
• • 8. 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.
• • 9. Pregnancy and lactation
• • 10. Severe hepatic dysfunction (serum albumin \< 25 g/l or Child-Pugh score ≥ 10).
• • 11. Estimated renal creatinine clearance \< 30 mL/min.
• • 12. Children and adolescents under 16 years of age.
• • 13. Inflammatory bowel disease.
• • 14. Congestive heart failure (NYHA II-IV).
• • 15. Patients with hypertension whose blood pressure has not been adequately controlled.
• • 16. Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, unstable angina.
• • 17. Patient has undergone coronary artery bypass graft surgery, angioplasty, or had myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.
• • 18. History of drug abuse.