Pain, Pain, Acute, Anesthesia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
30 mcg of sublingual sufentanil
DRUGIV Fentanyl
50 mcg of IV fentanyl
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* undergoing outpatient ambulatory surgery * recipient of general anesthesia * pain score of 4 or greater in the PACU
Exclusion criteria
* non-english speaking patients * cancer surgeries * patients who have allergy or intolerance to the study drugs or derivatives * patients on chronic opioids (defined as daily opioids for 3 months or longer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Room Time | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge) | 1 day | 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. |
| Adverse Events | 1 day | Number of serious adverse events (grades 3, 4, and 5) experienced by each group |
| Postoperative Nausea and Vomiting (PONV) | 1 day | Number of participants in each arm who are treated for nausea and/or vomiting. |
| Supplemental Oxygen | 1 day | Number of participants in each arm who require supplemental oxygen therapy |
| Overall Benefit of Analgesic Score (OBAS) | 1 day | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Sublingual Sufentanil Single dose of sublingual sufentanil for acute pain.
Sublingual Sufentanil: 30 mcg sublingual sufentanil tablet | 35 |
| IV Fentanyl single dose of IV fentanyl for acute pain.
IV Fentanyl: 50 mcg of IV fentanyl | 40 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 7 |
Baseline characteristics
| Characteristic | IV Fentanyl | Total | Sublingual Sufentanil |
|---|---|---|---|
| Age, Continuous | 37 years | 42 years | 52 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 40 participants | 75 participants | 35 participants |
| Sex: Female, Male Female | 24 Participants | 46 Participants | 22 Participants |
| Sex: Female, Male Male | 16 Participants | 29 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 40 |
| other Total, other adverse events | 4 / 35 | 7 / 40 |
| serious Total, serious adverse events | 0 / 35 | 0 / 40 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sublingual Sufentanil | Recovery Room Time | 73.0 minutes |
| IV Fentanyl | Recovery Room Time | 65.0 minutes |
Secondary
Adverse Events
Number of serious adverse events (grades 3, 4, and 5) experienced by each group
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sublingual Sufentanil | Adverse Events | 0 SAEs |
| IV Fentanyl | Adverse Events | 0 SAEs |
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.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sublingual Sufentanil | Overall Benefit of Analgesic Score (OBAS) | 3.0 score on a scale |
| IV Fentanyl | Overall Benefit of Analgesic Score (OBAS) | 3.0 score on a scale |
Secondary
Postoperative Nausea and Vomiting (PONV)
Number of participants in each arm who are treated for nausea and/or vomiting.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sublingual Sufentanil | Postoperative Nausea and Vomiting (PONV) | 4 Participants |
| IV Fentanyl | Postoperative Nausea and Vomiting (PONV) | 7 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.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sublingual Sufentanil | Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge) | 15.0 milligram morphine equivalents |
| IV Fentanyl | Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge) | 22.5 milligram morphine equivalents |
Secondary
Supplemental Oxygen
Number of participants in each arm who require supplemental oxygen therapy
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sublingual Sufentanil | Supplemental Oxygen | 4 Participants |
| IV Fentanyl | Supplemental Oxygen | 4 Participants |