Phase 4
N=258
CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial
Catheter-related Bladder Discomfort
Bottom Line
View on ClinicalTrials.gov: NCT00771173 ↗Enrolled (actual)
258
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments — 0.95; 0.97 centimeters — p=.745
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- phenazopyridine HCl (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Loyola University
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments |
0.95; 0.97 | .745 |
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 gynecologic patient using mean VAS measurments.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00771173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.