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Sponsored by: |
Loyola University |
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Information provided by: | Loyola University |
ClinicalTrials.gov Identifier: | NCT00771173 |
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.
The secondary aim is to compare overall post operative pain medication requirements, including cumulative dose and patterns of medication utilization between groups.
Condition | Intervention | Phase |
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Interstitial Cystitis |
Drug: phenazopyridine HCl Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project |
Estimated Enrollment: | 200 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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
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Drug: phenazopyridine HCl
Phenazopyrdine HCl 200 mg q8h x 24
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2: Placebo Comparator
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.
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Other: Placebo
Placebo tablet administered q8 hours for 24 hours postop.
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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 measurments.
The secondary aim is to compare overall post operative pain medication requirements, including cumulative dose and patterns of medication utilization between groups. The tertiary aim is to determine whether blinding is feasible in such a clinical trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
Known contraindications to phenazopyridine HCl:
Contact: Lisa Guilfoyle | 708-219-4657 | lguilfo@lumc.edu |
United States, Illinois | |
Loyola Univeristy Medical Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Elaine Fluder, MSN | |
Sub-Investigator: Charles Anderson, MD | |
Sub-Investigator: Maryann Chimhanda, MD | |
Sub-Investigator: Jayme Sloan, MD | |
Sub-Investigator: Suzanne Galloway, MD | |
Sub-Investigator: James Sinacore, PhD |
Principal Investigator: | Linda Brubaker, MD | Loyola University |
Responsible Party: | Loyola University Chicago, Stritch School of Medicine ( Linda Brubaker ) |
Study ID Numbers: | 201073 |
Study First Received: | October 9, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00771173 History of Changes |
Health Authority: | United States: Institutional Review Board |
Phenazopyrdine post operative bladder catheritization VAS scores Bladder pain related to indwelling foley catheters. Bladder irritaion related to indwelling foley catheters. |
Cystitis, Interstitial Cystocele Urologic Diseases |
Urinary Bladder Diseases Cystitis Pain |
Cystitis, Interstitial Urologic Diseases Urinary Bladder Diseases Cystitis |