Trial Outcomes & Findings for Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment (NCT NCT04716413)
NCT ID: NCT04716413
Last Updated: 2023-07-19
Results Overview
Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).
TERMINATED
PHASE4
3 participants
During day of surgery
2023-07-19
Participant Flow
Participant milestones
| Measure |
Treatment
Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV.
Dsuvia: Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)
|
Control
Subjects will be receive routine standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
Baseline characteristics by cohort
| Measure |
Treatment
n=3 Participants
Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV.
Dsuvia: Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)
|
Control
Subjects will be receive routine standard of care.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During day of surgeryPopulation: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During stay in PACU, up until discharge from PACUPopulation: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
How much time did subject take to become considered 'fit to discharge?'
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PACU stay to 24 hours post hospital dischargePopulation: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
A measure of how any additional opioids subjects were administered
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours post hospital dischargePopulation: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Average time for administration of first additional opioid.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During PACU stay, up until discharge from PACUPopulation: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Control
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