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Maywood, Illinois 60153


Purpose:

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. The secondary aim is to compare overall post operative pain medication requirements, including cumulative dose and patterns of medication utilization between groups.


Study summary:

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 catheterized following in-patient gynecologic surgery. Hypothesis and Aims: We plan to test the null hypothesis that there is no difference in post-operative pain as measured by VAS pain scores and pain medication requirements in women with a foley catheter following gynecologic surgery that are given phenazopyridine HCl vs. placebo. 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. The secondary aim is to compare overall post operative pain medication requirements, including cumulative dose and patterns of medication utilization between groups. The tertiary aim is to determine whether blinding is feasible in such a clinical trial.


Criteria:

Inclusion Criteria: 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 Criteria: 1. Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products). 2. 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. 3. Simultaneous suprapubic catheterization. 4. Inability to take oral medication within 12 hours after surgery. 5. Pregnant women.


NCT ID:

NCT00771173


Primary Contact:

Principal Investigator
Linda Brubaker, MD
Loyola University


Backup Contact:

N/A


Location Contact:

Maywood, Illinois 60153
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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