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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00440739
Enrollment
128
Registered
2007-02-27
Start date
2005-09-30
Completion date
2007-12-31
Last updated
2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

postoperative pain, etoticoxib, etoricoxib, Pain relief after transurethral resection of prostate.

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.

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.

Interventions

DRUGetoricoxib

etoricoxib 120 mg

DRUGflavoxate

flavoxate 200 mg 3 times

DRUGetoricoxib, flavoxate

etoricoxib 120 mg once and flavoxate 200 mg 3 times

DRUGplacebo

placebo once and placebo 3 times

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The patients' total amount of morphine requirement in the first 24 hour.24 hour

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026