A Phase 4 interventional study of Sublingual Sufentanil and IV Fentanyl in Pain, Pain, Acute and Anesthesia, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by University of Minnesota · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if a single dose of sublingual sufentanil is as or more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.
This is a level I randomized prospective outcomes study comparing two groups of patients. Upon arrival in the ambulatory surgery center (ASC) post-anesthesia care unit (PACU) if the patient has a pain score of 4 or greater they will then be randomized to one of two groups. Group 1 will receive 50 mcg of IV fentanyl and group 2 will receive 30 mcg of sublingual sufentanil. The primary outcome assessed will be time of readiness to discharge after arrival in the post-anesthesia care unit.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 75 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of sublingual sufentanil for acute pain.
Drug: Sublingual Sufentanil
single dose of IV fentanyl for acute pain.
Drug: IV Fentanyl
30 mcg of sublingual sufentanil
50 mcg of IV fentanyl
Recovery Room Time
The time (reported in minutes) from when the patient arrives in the PACU, right after surgery, to the time that all discharge criteria are met.
Time frame: 1 day
Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)
All doses of opioid medications administered following initial dosage (sufentanil or fentanyl depending on study arm) will be converted to milligram morphine equivalents and summed for reporting.
Time frame: 1 day
Adverse Events
Number of serious adverse events (grades 3, 4, and 5) experienced by each group
Time frame: 1 day
Postoperative Nausea and Vomiting (PONV)
Number of participants in each arm who are treated for nausea and/or vomiting.
Time frame: 1 day
Supplemental Oxygen
Number of participants in each arm who require supplemental oxygen therapy
Time frame: 1 day
Overall Benefit of Analgesic Score (OBAS)
Overall Benefit of Analgesic Score (OBAS) is a 7-item multi-dimensional survey that assesses analgesia benefits. Items are scored on a scale from 0 (minimal) to 4 (maximal). Total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy.
Time frame: 1 day
| Milestone | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Started | 35 | 40 |
| Completed | 33 | 33 |
| Not completed | 2 | 7 |
| Withdrew: Protocol violation | 2 | 7 |
The time (reported in minutes) from when the patient arrives in the PACU, right after surgery, to the time that all discharge criteria are met.
| minutes | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Recovery Room Time | 73.0 (56.0 to 89.0) | 65.0 (56.0 to 89.0) |
All doses of opioid medications administered following initial dosage (sufentanil or fentanyl depending on study arm) will be converted to milligram morphine equivalents and summed for reporting.
| milligram morphine equivalents | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge) | 15.0 (7.5 to 30.0) | 22.5 (13.1 to 23.4) |
Number of serious adverse events (grades 3, 4, and 5) experienced by each group
| SAEs | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Adverse Events | 0 | 0 |
Number of participants in each arm who are treated for nausea and/or vomiting.
| Participants | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Postoperative Nausea and Vomiting (PONV) | 4 | 7 |
Number of participants in each arm who require supplemental oxygen therapy
| Participants | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Supplemental Oxygen | 4 | 4 |
Overall Benefit of Analgesic Score (OBAS) is a 7-item multi-dimensional survey that assesses analgesia benefits. Items are scored on a scale from 0 (minimal) to 4 (maximal). Total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy.
| score on a scale | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Overall Benefit of Analgesic Score (OBAS) | 3.0 (2.0 to 4.0) | 3.0 (1.0 to 4.5) |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sublingual Sufentanil | 0/35 (0%) | 0/35 (0%) | 4/35 (11.4%) |
| IV Fentanyl | 0/40 (0%) | 0/40 (0%) | 7/40 (17.5%) |
| Event | Sublingual Sufentanil | IV Fentanyl |
|---|---|---|
| Postoperative nauseaSurgical and medical procedures | 4/35 | 7/40 |
| Age, Continuous(years) | Sublingual Sufentanil | IV Fentanyl | Total |
|---|---|---|---|
| Median | 52 (32.5 to 58) | 37 (22.75 to 53.75) | 42 (25.5 to 58) |
| Sex: Female, Male(Participants) | Sublingual Sufentanil | IV Fentanyl | Total |
|---|---|---|---|
| Female | 22 | 24 | 46 |
| Male | 13 | 16 | 29 |
| Race and Ethnicity Not Collected(Participants) | Sublingual Sufentanil | IV Fentanyl | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Sublingual Sufentanil | IV Fentanyl | Total |
|---|---|---|---|
| United States | 35 | 40 | 75 |
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