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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00440739
First received: February 2, 2006
Last updated: February 4, 2009
Last verified: February 2007

February 2, 2006
February 4, 2009
September 2005
December 2007   (final data collection date for primary outcome measure)
The patients' total amount of morphine requirement in the first 24 hour. [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
The patients' total amount of morphine requirement in the first 24 hour.
Complete list of historical versions of study NCT00440739 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)
Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: etoricoxib
    etoricoxib 120 mg
    Other Name: arcoxia
  • Drug: flavoxate
    flavoxate 200 mg 3 times
    Other Name: urispas
  • Drug: etoricoxib, flavoxate
    etoricoxib 120 mg once and flavoxate 200 mg 3 times
    Other Names:
    • arcoxia
    • urispas
  • Drug: placebo
    placebo once and placebo 3 times
    Other Name: placebo
  • Placebo Comparator: 1
    1=placebo
    Intervention: Drug: placebo
  • Active Comparator: 2
    2= etoricoxib
    Intervention: Drug: etoricoxib
  • Active Comparator: 3
    3=falvoxate
    Intervention: Drug: flavoxate
  • Active Comparator: 4
    etoricoxib and flavoxate
    Intervention: Drug: etoricoxib, flavoxate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00440739
SiEc 161/2548
No
Ethic committee Mahidol University, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Sirilak Suksompong, MD Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Mahidol University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP