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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

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ClinicalTrials.gov Identifier: NCT00763685
Recruitment Status : Terminated (The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.)
First Posted : October 1, 2008
Last Update Posted : January 31, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tiina Arumagi, East Tallinn Central Hospital

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.


Condition or disease Intervention/treatment Phase
Pain Drug: etoricoxib Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Active Comparator: etoricoxib 120 mg
active control
Drug: etoricoxib
etoricoxib 120 mg, paracetamol 1 g
Placebo Comparator: 2
Placebo
Drug: etoricoxib
etoricoxib 120 mg, paracetamol 1 g
Active Comparator: 3
Paracetamol 1 g and etoricoxib 120 mg
Drug: etoricoxib
etoricoxib 120 mg, paracetamol 1 g



Primary Outcome Measures :
  1. Pain scale [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Vomiting [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763685


Locations
Estonia
East Tallinn Central Hospital
Tallinn, Estonia, 10138
Sponsors and Collaborators
East Tallinn Central Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Tiina Arumägi, MD East Tallinn Central Hospital

Responsible Party: Tiina Arumagi, anaesthesiologist, East Tallinn Central Hospital
ClinicalTrials.gov Identifier: NCT00763685     History of Changes
Other Study ID Numbers: 35195
EUDRACT 2008-004098-17
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Tiina Arumagi, East Tallinn Central Hospital:
preoperative pain prophylaxis
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Acetaminophen
Etoricoxib
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents