NCT00771173

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Catheter-related Bladder Discomfort

Interventions

Type	Name	Description
DRUG	phenazopyridine HCl	Phenazopyrdine HCl 200 mg q8h x 24
OTHER	Placebo	Placebo tablet administered q8 hours for 24 hours postop.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-10-13
• Last updated: 2016-09-29
• Results posted: 2015-06-11

Locations

1 site across 1 country: United States