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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual Sufentanil | Experimental | Single dose of sublingual sufentanil for acute pain. |
|
| IV Fentanyl | Active Comparator | single dose of IV fentanyl for acute pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual Sufentanil | Drug | 30 mcg of sublingual sufentanil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron M Berg, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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Participants were assigned to groups after undergoing their surgical procedures if they had a self-reported pain score of 4 and above on the 11-point numeric rating scale during phase 1 of PACU.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sublingual Sufentanil | Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet |
| FG001 | IV Fentanyl | single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sublingual Sufentanil | Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet |
| BG001 | IV Fentanyl | single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | minutes | 1 day |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sublingual Sufentanil | Single dose of sublingual sufentanil for acute pain. Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative nausea | Surgical and medical procedures | Systematic Assessment | Postoperative nausea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonah Pearson | University of Minnesota | 218-280-8348 | 1 | pears731@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2019 | Jan 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| IV Fentanyl |
| Drug |
50 mcg of IV fentanyl |
|
Number of serious adverse events (grades 3, 4, and 5) experienced by each group |
| 1 day |
| Postoperative Nausea and Vomiting (PONV) | Number of participants in each arm who are treated for nausea and/or vomiting. | 1 day |
| Supplemental Oxygen | Number of participants in each arm who require supplemental oxygen therapy | 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. | 1 day |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | milligram morphine equivalents | 1 day |
|
|
|
| Secondary | Adverse Events | Number of serious adverse events (grades 3, 4, and 5) experienced by each group | Posted | Number | SAEs | 1 day |
|
|
|
| Secondary | Postoperative Nausea and Vomiting (PONV) | Number of participants in each arm who are treated for nausea and/or vomiting. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Supplemental Oxygen | Number of participants in each arm who require supplemental oxygen therapy | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 1 day |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 4 |
| 35 |
| EG001 | IV Fentanyl | single dose of IV fentanyl for acute pain. IV Fentanyl: 50 mcg of IV fentanyl | 0 | 40 | 0 | 40 | 7 | 40 |
|
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