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| Tracking Information | |||||
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| First Received Date ICMJE | February 2, 2006 | ||||
| Last Updated Date | February 4, 2009 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The patients' total amount of morphine requirement in the first 24 hour. [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The patients' total amount of morphine requirement in the first 24 hour. | ||||
| Change History | Complete list of historical versions of study NCT00440739 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP) | ||||
| Official Title ICMJE | Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Pain | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 128 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00440739 | ||||
| Responsible Party | Ethic committee Mahidol University, Mahidol University | ||||
| Study ID Numbers ICMJE | SiEc 161/2548 | ||||
| Study Sponsor ICMJE | Mahidol University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Mahidol University | ||||
| Verification Date | February 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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