Trial Outcomes & Findings for Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms (NCT NCT02865395)
NCT ID: NCT02865395
Last Updated: 2019-02-20
Results Overview
No results collected on the post-operative morphine equivalent dose
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
24 hours
Results posted on
2019-02-20
Participant Flow
Participant milestones
| Measure |
Pre-operative Suppository
A B\&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.
Belladonna and Opium Suppository
|
Post-operative Suppository
A B\&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.
Belladonna and Opium Suppository
|
Rectal Exam
Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.
Rectal Exam
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
7
|
Reasons for withdrawal
| Measure |
Pre-operative Suppository
A B\&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.
Belladonna and Opium Suppository
|
Post-operative Suppository
A B\&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.
Belladonna and Opium Suppository
|
Rectal Exam
Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.
Rectal Exam
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
6
|
10
|
7
|
Baseline Characteristics
Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 24 hoursPopulation: Study terminated prior to results.
No results collected on the post-operative morphine equivalent dose
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data was not collected on these patients.
Patients will be asked to fill out a short questionnaire with the faces scale to grade their pain on a scale of 1-10
Outcome measures
Outcome data not reported
Adverse Events
Pre-operative Suppository
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-operative Suppository
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rectal Exam
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