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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linda Brubaker, Loyola University
ClinicalTrials.gov Identifier:
NCT00771173
First received: October 9, 2008
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Catheter-related Bladder Discomfort
Drug: phenazopyridine HCl
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.


Enrollment: 258
Study Start Date: August 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: phenazopyridine HCl
Phenazopyrdine HCl 200 mg q8h x 24
Other Name: Pyridium
Placebo Comparator: 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.
Other: Placebo
Placebo tablet administered q8 hours for 24 hours postop.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00771173

Locations
United States, Illinois
Loyola Univeristy Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Linda Brubaker, MD Loyola University
  More Information

Publications:
Responsible Party: Linda Brubaker, Professor of Medicine and Dean and Chief Diversity Officer, Stritch School of Medicine, Loyola University
ClinicalTrials.gov Identifier: NCT00771173     History of Changes
Other Study ID Numbers: 201073
Study First Received: October 9, 2008
Results First Received: April 20, 2015
Last Updated: May 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
Phenazopyrdine
post operative bladder catheritization
VAS scores
Bladder pain related to indwelling foley catheters.
Bladder irritaion related to indwelling foley catheters.

ClinicalTrials.gov processed this record on June 30, 2015