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

NCT00771173 | Completed Phase 4 Results

• 1 other identifier: 201073
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Catheter-related Bladder Discomfort

Keywords

Phenazopyrdine; post operative bladder catheritization; VAS scores; Bladder pain related to indwelling foley catheters.; Bladder irritaion related to indwelling foley catheters.

Outcome Measures

Primary Outcomes (1)

• Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments

  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.

  24 hours

Study Arms (2)

Study Medication Group

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

Drug: phenazopyridine HCl

Placebo tablet Group

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.

Other: Placebo

Interventions

phenazopyridine HCl DRUG

Phenazopyrdine HCl 200 mg q8h x 24

Also known as: Pyridium

Study Medication Group

Placebo OTHER

Placebo tablet administered q8 hours for 24 hours postop.

Placebo tablet Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products).
• 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.
• Simultaneous suprapubic catheterization.
• Inability to take oral medication within 12 hours after surgery.
• Pregnant women.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola Univeristy Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (1)

• Anderson C, Chimhanda M, Sloan J, Galloway S, Sinacore J, Brubaker L. Phenazopyridine does not improve catheter discomfort following gynecologic surgery. Am J Obstet Gynecol. 2011 Mar;204(3):267.e1-3. doi: 10.1016/j.ajog.2010.12.045.

  PMID: 21376167 RESULT

MeSH Terms

Interventions

Phenazopyridine

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

One limitation of our study was inconsistent collection of our primary outcome data. Nursing staff and house staff failed to collect VAS scores consistently.

Results Point of Contact

• Title: Dr. Linda Brubaker
• Organization: Loyola University Chicago

lbrubaker@lumc.edu

708-216-3960

Study Officials

• Linda Brubaker, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Dean and Chief Diversity Officer, Stritch School of Medicine

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 13, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 29, 2016
• Results First Posted: June 11, 2015

Record last verified: 2016-08

Locations

US (1)