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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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

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Catheter-related Bladder Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study Medication Group

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

Group Type ACTIVE_COMPARATOR

phenazopyridine HCl

Intervention Type DRUG

Phenazopyrdine HCl 200 mg q8h x 24

Placebo tablet Group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet administered q8 hours for 24 hours postop.

Interventions

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phenazopyridine HCl

Phenazopyrdine HCl 200 mg q8h x 24

Intervention Type DRUG

Placebo

Placebo tablet administered q8 hours for 24 hours postop.

Intervention Type OTHER

Other Intervention Names

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Pyridium

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No