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

Loyola University

Status and phase: Completed; Phase 4

Conditions: Catheter-related Bladder Discomfort

Treatments: Drug: phenazopyridine HCl; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00771173

201073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 2 patient groups, including a placebo group

Study Medication Group

Active Comparator group

Description:

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

Treatment:

Drug: phenazopyridine HCl

Placebo tablet Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo