Acute Pain
Conditions
Brief summary
In this case series study, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care Unit (PACU) in ambulatory surgery patients taking Suboxone.
Interventions
DRUGDsuvia
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)
Sponsors
Montefiore Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age range 18-100 years * Currently taking Suboxone * ASA (American Society of Anesthesiology) physical score 1-3 * Able to provide a signed informed consent * General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia
Exclusion criteria
* Known allergic reactions to Dsuvia and its excipients * Severe respiratory illness including exacerbation of asthma attack * Significant intraoperative hemodynamic instability * Use of Regional anesthesia techniques
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalence | During day of surgery | Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit) | During stay in PACU, up until discharge from PACU | How much time did subject take to become considered 'fit to discharge?' |
| Need for Additional Opioids Following Surgery | PACU stay to 24 hours post hospital discharge | A measure of how any additional opioids subjects were administered |
| Time to Take the First Additional Opioid | 24 hours post hospital discharge | Average time for administration of first additional opioid. |
| Adverse Events in the PACU | During PACU stay, up until discharge from PACU | Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU |
| Adverse Events Post Discharge From PACU | 24 hours | Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 3 |
| Control Subjects will be receive routine standard of care. | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | — | 3 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Morphine Equivalence
Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).
Time frame: During day of surgery
Population: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Secondary
Adverse Events in the PACU
Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU
Time frame: During PACU stay, up until discharge from PACU
Population: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Secondary
Adverse Events Post Discharge From PACU
Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU
Time frame: 24 hours
Population: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Secondary
Need for Additional Opioids Following Surgery
A measure of how any additional opioids subjects were administered
Time frame: PACU stay to 24 hours post hospital discharge
Population: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Secondary
Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit)
How much time did subject take to become considered 'fit to discharge?'
Time frame: During stay in PACU, up until discharge from PACU
Population: Data was not collected/aggregated. As such there was no data analysis for this terminated study.
Secondary
Time to Take the First Additional Opioid
Average time for administration of first additional opioid.
Time frame: 24 hours post hospital discharge
Population: Data was not collected/aggregated. As such there was no data analysis for this terminated study.