Conditions: Catheter-related Bladder Discomfort
Keywords: Phenazopyrdine post operative bladder catheritization VAS scores Bladder pain related to indwelling foley catheters. Bladder irritaion related to indwelling foley catheters.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 258
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first arm 2: For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.

Interventions: intervention 1: phenazopyridine HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Phenazopyrdine HCl 200 mg q8h x 24 intervention 2: Placebo tablet administered q8 hours for 24 hours postop.

Protocol document: