Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)

Pain Clinical Trial

Official title:

Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440739
• Other study ID #: SiEc 161/2548
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2006
• Last updated: February 4, 2009
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2007
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• etoricoxib
etoricoxib 120 mg
• flavoxate
flavoxate 200 mg 3 times
• etoricoxib, flavoxate
etoricoxib 120 mg once and flavoxate 200 mg 3 times
• placebo
placebo once and placebo 3 times

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patients' total amount of morphine requirement in the first 24 hour.		24 hour	Yes