CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial

Loyola University258 enrolled

Overview

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.

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 measurements.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

258

Conditions

Catheter-related Bladder Discomfort

Interventions

phenazopyridine HClDRUG

Phenazopyrdine HCl 200 mg q8h x 24

PlaceboOTHER

Placebo tablet administered q8 hours for 24 hours postop.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Loyola Univeristy Medical Center

Maywood, Illinois, United States

Outcomes

Primary Outcomes

Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments

The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.

Time frame: 24 hours

Data from ClinicalTrials.gov

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