Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)
Information source: Mahidol University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: etoricoxib (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Sirilak Suksompong, MD, Principal Investigator, Affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Overall contact:
Sirilak Suksompong, MD, Phone: 662-411-3256, Email: sisuk@mahidol.ac.th
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.
Clinical Details
Official title: Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Primary outcome: The patients' total amount of morphine requirement in the first 24 hour.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Sirilak Suksompong, MD, Phone: 662-411-3256, Email: sisuk@mahidol.ac.th
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand; Recruiting
Sirilak Suksompong, MD, Phone: 662-411-3256, Email: sisuk@mahidol.ac.th
Sirilak Suksompong, MD, Principal Investigator
Additional Information
Starting date: September 2005
Last updated: August 22, 2007
|
