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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
History of Changes
  Purpose

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 Intervention Phase
Pain
 Drug: etoricoxib
Drug: flavoxate
Drug: etoricoxib, flavoxate
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The patients' total amount of morphine requirement in the first 24 hour. [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Enrollment: 128
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
1=placebo
 Drug: placebo
placebo once and placebo 3 times
Other Name: placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ethic committee Mahidol University, Mahidol University
ClinicalTrials.gov Identifier: NCT00440739     History of Changes
Other Study ID Numbers: SiEc 161/2548
Study First Received: February 2, 2006
Last Updated: February 4, 2009
Health Authority: Thailand: Food and Drug Administration

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

Additional relevant MeSH terms:
Flavoxate
Morphine
Etoricoxib
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Opioid
Analgesics
Sensory System Agents
Central Nervous System Agents
 Therapeutic Uses
Central Nervous System Depressants
Narcotics
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

ClinicalTrials.gov processed this record on May 16, 2013