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Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)

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ClinicalTrials.gov Identifier: NCT00440739
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : February 5, 2009
Sponsor:
Information provided by:
Mahidol University

Brief Summary:

The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after TURP.

The research hypothesis:

There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.


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

Detailed Description:

Postoperative pain is still a significant problem for surgical patients. Conventional use of narcotics for postoperative pain relief is not without serious side effects such as respiratory depression and sedation.There are other alternatives for postoperative analgesia as NSAIDs especially COX2-inhibitors. For some specific operation such as TURP which Foley's catheter needed to be retained for a few days,urinary anti spasmodics may help the patients to be more comfortable.

Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial
Study Start Date : September 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
1=placebo
Drug: placebo
placebo once and placebo 3 times
Active Comparator: 2
2= etoricoxib
Drug: etoricoxib
etoricoxib 120 mg
Other Name: arcoxia
Active Comparator: 3
3=falvoxate
Drug: flavoxate
flavoxate 200 mg 3 times
Other Name: urispas
Active Comparator: 4
etoricoxib and flavoxate
Drug: etoricoxib, flavoxate
etoricoxib 120 mg once and flavoxate 200 mg 3 times
Other Names:
  • arcoxia
  • urispas



Primary Outcome Measures :
  1. The patients' total amount of morphine requirement in the first 24 hour. [ Time Frame: 24 hour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male patient ASA physical status I-III.
  2. Scheduled for an elective TURP.
  3. Body weight > or = 50 kg
  4. Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

  1. History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
  2. Known hypersensitivity to morphine.
  3. History of hepatic dysfunction.
  4. Creatinine clearance < 30ml/min.
  5. History of bleeding tendency.
  6. History of gastrointestinal bleeding or active peptic ulcer.
  7. Known case of inflammatory bowel disease.
  8. Patient with severe heart failure.
  9. History of coronary artery disease or cerebrovascular disease.

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): NCT00440739


Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Sirilak Suksompong, MD Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand

Responsible Party: Ethic committee Mahidol University, Mahidol University
ClinicalTrials.gov Identifier: NCT00440739     History of Changes
Other Study ID Numbers: SiEc 161/2548
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2007

Keywords provided by Mahidol University:
postoperative pain, etoticoxib, etoricoxib
Pain relief after transurethral resection of prostate.

Additional relevant MeSH terms:
Morphine
Etoricoxib
Flavoxate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Parasympatholytics
Autonomic Agents
Urological Agents