Status:
TERMINATED
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
Lead Sponsor:
East Tallinn Central Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Pain
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
Primary Hypothesis: 1\. The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater than that of placebo in the treatment of postoperative pain.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00763685
Start Date
June 1 2010
End Date
November 1 2011
Last Update
January 31 2012
Active Locations (1)
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1
East Tallinn Central Hospital
Tallinn, Estonia, 10138