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

Catheter-related Bladder Discomfort Clinical Trial

Official title: THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project

Status Completed

Clinical Trial 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.

Clinical Trial 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 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheter-related Bladder Discomfort

• NCT number: NCT00771173
• Study type: Interventional
• Source: Loyola University
• Status: Completed
• Phase: Phase 4
• Start date: August 2008
• Completion date: January 2010