Trial Outcomes & Findings for The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain (NCT NCT03332056)
NCT ID: NCT03332056
Last Updated: 2023-06-18
Results Overview
Global quality of life score as measured by the Ureteral Stent Symptom Questionnaire (USSQ). Scale is 1-7 (Lower score indicating better quality of life compared to higher score). 1 = delighted, 2 = pleased, 3 = mostly satisfied, 4 = mixed feelings (about equally satisfied and dissatisfied), 5 = mostly dissatisfied, 6 = unhappy, 7 = terrible
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
postoperative day 1
Results posted on
2023-06-18
Participant Flow
Participant milestones
| Measure |
Belladonna and Opium (B&O) Suppository
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
placebo suppository
Placebo suppository
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Belladonna and Opium (B&O) Suppository
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
placebo suppository
Placebo suppository
|
|---|---|---|
|
Overall Study
Incomplete questionnaires
|
8
|
9
|
|
Overall Study
Passed stone prior to surgery date
|
1
|
0
|
|
Overall Study
Did not require a ureteral stent
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Belladonna and Opium (B&O) Suppository
n=35 Participants
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
n=36 Participants
placebo suppository
Placebo suppository
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 13 • n=35 Participants
|
50 years
STANDARD_DEVIATION 16 • n=36 Participants
|
53 years
STANDARD_DEVIATION 15 • n=71 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=35 Participants
|
20 Participants
n=36 Participants
|
37 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=35 Participants
|
16 Participants
n=36 Participants
|
34 Participants
n=71 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
36 participants
n=36 Participants
|
71 participants
n=71 Participants
|
PRIMARY outcome
Timeframe: postoperative day 1Global quality of life score as measured by the Ureteral Stent Symptom Questionnaire (USSQ). Scale is 1-7 (Lower score indicating better quality of life compared to higher score). 1 = delighted, 2 = pleased, 3 = mostly satisfied, 4 = mixed feelings (about equally satisfied and dissatisfied), 5 = mostly dissatisfied, 6 = unhappy, 7 = terrible
Outcome measures
| Measure |
Belladonna and Opium (B&O) Suppository
n=35 Participants
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
n=34 Participants
placebo suppository
Placebo suppository
|
|---|---|---|
|
Global Quality of Life Score on Postoperative Day 1
|
4.4 score on a scale
Standard Deviation 0.6
|
5.4 score on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: postoperative day 3Global quality of life score as measured by the Ureteral Stent Symptom Questionnaire (USSQ). Scale is 1-7 (Lower score indicating better quality of life compared to higher score). 1 = delighted, 2 = pleased, 3 = mostly satisfied, 4 = mixed feelings (about equally satisfied and dissatisfied), 5 = mostly dissatisfied, 6 = unhappy, 7 = terrible
Outcome measures
| Measure |
Belladonna and Opium (B&O) Suppository
n=35 Participants
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
n=34 Participants
placebo suppository
Placebo suppository
|
|---|---|---|
|
Global Quality of Life Score on Postoperative 3
|
4.5 score on a scale
Standard Deviation 1.4
|
5.6 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 14 days post-opPopulation: Adverse reactions in the intervention group
To assess postoperative complications as a result of the use of B\&O suppository, including urinary retention.
Outcome measures
| Measure |
Belladonna and Opium (B&O) Suppository
n=35 Participants
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
placebo suppository
Placebo suppository
|
|---|---|---|
|
Number of Participants With Postoperative Complications as a Result of the Use of B&O Suppository
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 14 days post-opNumber of postoperative unanticipated visits including nursing visits and ED visits
Outcome measures
| Measure |
Belladonna and Opium (B&O) Suppository
n=35 Participants
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
n=34 Participants
placebo suppository
Placebo suppository
|
|---|---|---|
|
Number of Participants With Unanticipated Postoperative Visits
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 14 days post-opMeasurement of postoperative opiate use using a questionnaire. We will define success as a reduction in postoperative narcotic use by 10% compared to placebo.
Outcome measures
| Measure |
Belladonna and Opium (B&O) Suppository
n=35 Participants
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
n=34 Participants
placebo suppository
Placebo suppository
|
|---|---|---|
|
Measurement of Post-operative Narcotic Use
|
55 morphine milligram equivalents
Standard Deviation 76
|
65 morphine milligram equivalents
Standard Deviation 79
|
Adverse Events
Belladonna and Opium (B&O) Suppository
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Suppository
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Belladonna and Opium (B&O) Suppository
n=35 participants at risk
A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain.
Belladonna and Opium
|
Placebo Suppository
n=34 participants at risk
placebo suppository
Placebo suppository
|
|---|---|---|
|
General disorders
Emergency Department visits
|
8.6%
3/35 • Number of events 3
|
14.7%
5/34 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place