Trial Outcomes & Findings for CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial (NCT NCT00771173)
NCT ID: NCT00771173
Last Updated: 2016-09-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
258 participants
Primary outcome timeframe
24 hours
Results posted on
2016-09-29
Participant Flow
Participants were enrolled from September 2008 through December 2009 at the 2 Loyola system hospitals.
All enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis was due to inconsistent collection of our primary outcome data. Nursing staff and house staff failed to collect VAS scores consistently.
Participant milestones
| Measure |
Placebo 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.
Blinding: The research pharmacist has facilitated the blinding by placing the active agent (200 mg tablets) into a solid colored capsule. She will make matching placebo capsules filled with lactose powder. To aid in blinding and avoid systemic administration of other dye agents for women in the placebo group, a small amount of orange dye will be placed in the Foley bag. This has been tested in the planning for this trial and is known effectively color the urine orange.
|
Active Agent 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
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
129
|
|
Overall Study
COMPLETED
|
107
|
112
|
|
Overall Study
NOT COMPLETED
|
22
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Active Agent Group
n=129 Participants
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
phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24
|
Placebo Group
n=129 Participants
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.
Placebo: Placebo tablet administered q8 hours for 24 hours postop.
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
53 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex/Gender, Customized
Women
|
129 participants
n=5 Participants
|
129 participants
n=7 Participants
|
258 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Per Protocol
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.
Outcome measures
| Measure |
Active Agent Group
n=112 Participants
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
phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24
|
Placebo Group
n=107 Participants
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.
Placebo: Placebo tablet administered q8 hours for 24 hours postop.
|
|---|---|---|
|
Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments
|
0.95 centimeters
Standard Deviation 1.8
|
0.97 centimeters
Standard Deviation 1.7
|
Adverse Events
Active Agent Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place