PainPhase 4NCT04177862
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
A Phase 4 study testing Sublingual Sufentanil and IV Fentanyl in people with Pain and Pain, Acute, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Pain, Acute, Anesthesia
- What is being tested?
- Sublingual Sufentanil and IV Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2019to 31 Jan 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing outpatient ambulatory surgery
- recipient of general anesthesia
- pain score of 4 or greater in the PACU
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Pain, Pain, Acute, Anesthesia
- Being tested
- Sublingual Sufentanil, IV Fentanyl
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual SufentanilDrug
30 mcg of sublingual sufentanil
IV FentanylDrug
50 mcg of IV fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Sufentanil | Experimental | Single dose of sublingual sufentanil for acute pain. Receives: Drug: Sublingual Sufentanil |
| IV Fentanyl | Active comparator | single dose of IV fentanyl for acute pain. Receives: Drug: IV Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 1 day
Adverse Events
Number of serious adverse events (grades 3, 4, and 5) experienced by each group
Measured: 1 day
Postoperative Nausea and Vomiting (PONV)
Number of participants in each arm who are treated for nausea and/or vomiting.
Measured: 1 day
Supplemental Oxygen
Number of participants in each arm who require supplemental oxygen therapy
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start11 Dec 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron M Berg, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177862
- Sponsor's protocol ID
- ANES-2019-28303
- Status last verified
- Apr 2021
- First submitted
- 22 Nov 2019
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
- ClinicalTrials.gov ID
- NCT04177862
- Acronym / sponsor ID
- ANES-2019-28303
- Conditions
- Pain, Pain, Acute, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Sufentanil | Experimental | Drug: Sublingual SufentanilSingle dose of sublingual sufentanil for acute pain. |
| IV Fentanyl | Active comparator | Drug: IV Fentanylsingle dose of IV fentanyl for acute pain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing outpatient ambulatory surgery
- recipient of general anesthesia
- pain score of 4 or greater in the PACU
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual Sufentanil30 mcg of sublingual sufentanil | Drug | Sublingual Sufentanil |
| IV Fentanyl50 mcg of IV fentanyl | Drug | IV Fentanyl |
Primary outcome
Recovery Room Time
Time frame: 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.
5 secondary outcomes
Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)
Time frame: 1 day
Adverse Events
Time frame: 1 day
Postoperative Nausea and Vomiting (PONV)
Time frame: 1 day
Supplemental Oxygen
Time frame: 1 day
Overall Benefit of Analgesic Score (OBAS)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron M Berg, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sublingual Sufentanil and IV Fentanyl in people with Pain and Pain, Acute, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery Room Time (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.