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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

1=placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo once and placebo 3 times

2

2= etoricoxib

Group Type ACTIVE_COMPARATOR

etoricoxib

Intervention Type DRUG

etoricoxib 120 mg

3

3=falvoxate

Group Type ACTIVE_COMPARATOR

flavoxate

Intervention Type DRUG

flavoxate 200 mg 3 times

4

etoricoxib and flavoxate

Group Type ACTIVE_COMPARATOR

etoricoxib, flavoxate

Intervention Type DRUG

etoricoxib 120 mg once and flavoxate 200 mg 3 times

Interventions

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etoricoxib

etoricoxib 120 mg

Intervention Type DRUG

flavoxate

flavoxate 200 mg 3 times

Intervention Type DRUG

etoricoxib, flavoxate

etoricoxib 120 mg once and flavoxate 200 mg 3 times

Intervention Type DRUG

placebo

placebo once and placebo 3 times

Intervention Type DRUG

Other Intervention Names

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arcoxia urispas arcoxia urispas

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No