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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

Page last updated: August 23, 2015

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