CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial
Information source: Loyola University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Catheter-related Bladder Discomfort
Intervention: phenazopyridine HCl (Drug); Placebo (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Loyola University Official(s) and/or principal investigator(s): Linda Brubaker, MD, Principal Investigator, Affiliation: Loyola University
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.
Clinical Details
Official title: THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Loyola Univeristy Medical Center, Maywood, Illinois 60153, United States
Additional Information
Starting date: August 2008
Last updated: May 27, 2015
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