Status:
COMPLETED
CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial
Lead Sponsor:
Loyola University
Conditions:
Catheter-related Bladder Discomfort
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gyneco...
Detailed Description
This is a randomized clinical trial to determine whether phenazopyridine HCl reduces catheter-related bladder discomfort, using mean VAS scores and overall pain medicine requirements in women catheter...
Eligibility Criteria
Inclusion
- 1\. Adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication.
Exclusion
- Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products).
- Known contraindications to phenazopyridine HCl:
- Renal failure or insufficiency (Defined as having abnormal renal function on previous laboratory testing (BUN/Cr) or as having a known renal disease).
- History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs).
- Known glucose-6-phosphate dehydrogenase deficiency.
- Simultaneous suprapubic catheterization.
- Inability to take oral medication within 12 hours after surgery.
- Pregnant women.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00771173
Start Date
August 1 2008
End Date
January 1 2010
Last Update
September 29 2016
Active Locations (1)
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1
Loyola Univeristy Medical Center
Maywood, Illinois, United States, 60153