Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP) - Full Text View

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00440739

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: etoricoxib	Phase IV

Drug Information available for: Etoricoxib Flavoxate Flavoxate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial

Further study details as provided by Mahidol University:

Primary Outcome Measures:

The patients' total amount of morphine requirement in the first 24 hour. [ Time Frame: 24 hour ]

Estimated Enrollment:	128
Study Start Date:	September 2005

Arms	Assigned Interventions
1,2,3,4: Placebo Comparator placebo etoricoxib flavoxate etoricoxib and flavoxate	Drug: etoricoxib placebo etoricoxib 120 mg oral single dose flavoxate 200 mg three times every 6 hour etoricoxib 120 mg oral single dose and flavoxate 200 mg three times every 6 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male patient ASA physical status I-III.
Scheduled for an elective TURP.
Body weight > or = 50 kg
Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
Known hypersensitivity to morphine.
History of hepatic dysfunction.
Creatinine clearance < 30ml/min.
History of bleeding tendency.
History of gastrointestinal bleeding or active peptic ulcer.
Known case of inflammatory bowel disease.
Patient with severe heart failure.
History of coronary artery disease or cerebrovascular disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440739

Contacts

Contact: Sirilak Suksompong, MD

662-411-3256

sisuk@mahidol.ac.th

Locations

Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University	Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD 662-411-3256 sisuk@mahidol.ac.th
Principal Investigator: Sirilak Suksompong, MD

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator:

Sirilak Suksompong, MD

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand

More Information

Study ID Numbers:	SiEc 161/2548
Study First Received:	February 2, 2006
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00440739
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Mahidol University:

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

Study placed in the following topic categories:

Morphine
Etoricoxib
Pain
Flavoxate
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Parasympatholytics
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Autonomic Agents

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009