CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial
Completed · Phase 4 · Has a placebo group
Conditions studied: Catheter-related Bladder Discomfort
In brief
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 gynecologic patient using mean VAS measurments.
Key facts
- Study ID
- NCT00771173
- Run by
- Loyola University
- People needed
- 258
- Starts
- 2008-08-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2016-09-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Loyola Univeristy Medical Center — Maywood, Illinois, United States
Full record on ClinicalTrials.gov
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