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Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)
This study has been completed.
Study NCT00440739   Information provided by Mahidol University
First Received: February 2, 2006   Last Updated: February 4, 2009   History of Changes

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
 
 
 
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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Pain
  • Drug: etoricoxib
  • Drug: flavoxate
  • Drug: etoricoxib, flavoxate
  • Drug: placebo
  • Placebo Comparator: 1=placebo
  • Active Comparator: 2= etoricoxib
  • Active Comparator: 3=falvoxate
  • Active Comparator: etoricoxib and flavoxate
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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
Ethic committee Mahidol University, Mahidol University
SiEc 161/2548
Mahidol University
 
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