Clinical trial NCT04177862
Conditions: Pain Pain, Acute Anesthesia
Sponsor: University of Minnesota
Start date: 2019-12-11; Completion date: 2020-01-31
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Single dose of sublingual sufentanil for acute pain. arm 2: single dose of IV fentanyl for acute pain.
Interventions: intervention 1: Sublingual Sufentanil intervention 2: IV Fentanyl
Intervention descriptions: intervention 1: 30 mcg of sublingual sufentanil intervention 2: 50 mcg of IV fentanyl

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL TITLE: Sublingual sufentanil vs Intravenous fentanyl for acute pain in the 
Ambulatory Surgery Center - STUDY00007956 
VERSION DATE: 3 12/20/2019 
 
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INSTRUCTIONS: 
 
Protocol Title 
Sublingual sufentanil vs Intravenous fentanyl for acute pain in 
the ambulatory surgery center.  
Principal 
Investigator/Faculty 
Advisor 
Name: Aaron Berg 
Department: Anesthesiology 
Telephone Number: 612-624-9990 
Email Address: bergx831@umn.edu 
Student 
Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
N/A 
IND/IDE # (if 
applicable) 
N/A 
IND/IDE Holder 
N/A 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
3 12/20/2019 
 
PROTOCOL COVER PAGE 
 
 
 
 


PROTOCOL TITLE: Sublingual sufentanil vs Intravenous fentanyl for acute pain in the 
Ambulatory Surgery Center - STUDY00007956 
VERSION DATE: 3 12/20/2019 
 
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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
2 
12/5/2019 
Modifications for approval 
Yes 
3 
12/20/2019 
Protocol timing adjustment 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


PROTOCOL TITLE: Sublingual sufentanil vs Intravenous fentanyl for acute pain in the 
Ambulatory Surgery Center - STUDY00007956 
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Table of Contents 
 
1.0 
Objectives 
5 
2.0 
Background 
5 
3.0 
Study Endpoints/Events/Outcomes 
5 
4.0 
Study Intervention(s)/Investigational Agent(s) 
5 
5.0 
Procedures Involved 
5 
6.0 
Data and Specimen Banking 
7 
7.0 
Sharing of Results with Participants 
7 
8.0 
Study Population 
7 
9.0 
Vulnerable Populations 
7 
10.0 Local Number of Participants 
9 
11.0 Local Recruitment Methods 
9 
12.0 Withdrawal of Participants 
9 
13.0 Risks to Participants 
10 
14.0 Potential Benefits to Participants 
10 
15.0 Statistical Considerations 
10 
16.0 Confidentiality 
11 
17.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
11 
18.0 Provisions to Protect the Privacy Interests of Participants 
12 
19.0 Compensation for Research-Related Injury 
12 
20.0 Consent Process 
12 
21.0 Setting 
13 
22.0 Multi-Site Research 
13 
23.0 Resources Available 
13 
24.0 References 
14 
 


PROTOCOL TITLE: Sublingual sufentanil vs Intravenous fentanyl for acute pain in the 
Ambulatory Surgery Center - STUDY00007956 
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ABBREVIATIONS/DEFINITIONS 
● SST: Sublingual Sufentanil Tablet 
● PACU: Post Anesthesia Care Unit 
● IV: Intravenous 
● ASC: Ambulatory Surgery Center 
● SIS: Six Item Screener 
● PONV: Postoperative Nausea and Vomiting  
 
 
 


PROTOCOL TITLE: Sublingual sufentanil vs Intravenous fentanyl for acute pain in the 
Ambulatory Surgery Center - STUDY00007956 
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1.0 
Objectives 
1.1 Purpose: 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.   
2.0 
Background 
2.1 Significance of Research Question/Purpose: This study will help to 
determine the appropriate place for use of sublingual sufentanil in an 
ambulatory practice.   
2.2 Preliminary Data: Existing Literature: Previous studies have demonstrated 
the superiority of SST to placebo when used for abdominal surgery. 
Additional open label studies have demonstrated that SST has no change in 
mental status when given in an emergency room setting and has a safe 
adverse event profile when used in various inpatient surgical procedures.  
No studies have compared SST 30 mcg to an active comparator such as IV 
fentanyl.   
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: Time of readiness to discharge after 
arrival in PACU 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): opioid use after intervention 
until discharge, adverse events, patient satisfaction, PONV, supplemental 
oxygen, and OBAS score 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description: Upon arrival in the ASC PACU patients who have a pain score 
of 4 or greater will receive one of two interventions.  They will be randomly 
assigned to receive either 50 mcg of IV fentanyl or 30 mcg of sublingual 
sufentanil.  Fentanyl is a potent IV opioid whereas sufentanil is a potent 
sublingual opioid.   
4.2 Drug/Device Handling: Both sublingual sufentanil and IV fentanyl will be 
stored in the PACU pyxis like other controlled substances.   
4.3 Biosafety: n/a  
4.4 Stem Cells: n/a 
 
5.0 
Procedures Involved 
5.1 Study Design: This is a level I randomized prospective outcomes study 
comparing two groups of patients.  Upon arrival in the ASC 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.   


PROTOCOL TITLE: Sublingual sufentanil vs Intravenous fentanyl for acute pain in the 
Ambulatory Surgery Center - STUDY00007956 
VERSION DATE: 3 12/20/2019 
 
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5.2 
Study Procedures: Patients will be approached on the day of surgery about 
participating in the trial.  This will be done as soon as they arrive at the ASC 
to allow adequate time for them to review the study procedures and 
consent form.  All questions will be answered and patients will be ensured 
that they have adequate time to review and understand all study 
procedures.  Patients undergoing surgical procedures with general 
anesthesia will be eligible to participate. Once consented a baseline six-
item screener score will be obtained.   Patients will only be enrolled once 
they reach the PACU and if their pain score is 4/10 or greater via the 
Numerical Rating Scale. Then they will be randomized and enrolled in the 
study.  If they never have a pain score of 4 or greater they will not be 
enrolled.    
All patients will have received preoperative acetaminophen 975 mg, 
gabapentin 300 mg and a standardized opioid sparing total IV anesthetic 
with propofol.  No opioids will be used on induction and patients will only 
receive intraoperative opioids if their HR or BP is increased by 20% above 
baseline.  2 different PONV prophylaxis (ondansetron and dexamethasone) 
will be given and Ketamine will not be used in this study.  
Once in PACU, if their pain score is 4 or greater on a Numerical rating scale 
they will be randomized into one of the two groups. One group will receive 
50 mcg of IV fentanyl and the other will receive 30 mcg of sublingual 
sufentanil.  They will be eligible to receive additional rescue opioids 10 
minutes after their first dose.  Rescue opioids will be 25 mcg of IV fentanyl 
given up to every 3 minutes for max dose of 100 mcg (max dose will count 
only rescue IV fentanyl, but not the initial randomization of IV fentanyl 50 
mcg) if pain score remains at 4 or greater out of 10 during this time. If pain 
scores are 3 or less, no opioids will be given.  After 100 mcg of rescue 
fentanyl if pain score remains above 4 out of 10 they will receive 5 mg of 
oral oxycodone or 2 mg of oral hydromorphone if allergic to oxycodone. 
Another six-item screener test will occur 30 minutes after administration of 
sublingual sufentanil or initial IV fentanyl. 
Time until readiness to discharge (minutes), rescue opioid use (mcgs), 
Overall benefit of analgesia score, PONV (defined as needed to treat or 
not), need for supplemental oxygen (at 30 mins into recovery) and patient 
satisfaction will be recorded. Six-item screener scores, Baseline 
demographics such as surgical procedure, intraoperative opioids, surgical 
procedure length, BMI, weight, age, and sex will be recorded.   
5.3 Study Duration: Once ready to discharge from PACU the patient recording 
will stop and they will finish participation by answering questions for the 
OBAS survey.  It should take 4 weeks to enroll all patients and another 2 
months for full data analysis.  


PROTOCOL TITLE: Sublingual sufentanil vs Intravenous fentanyl for acute pain in the 
Ambulatory Surgery Center - STUDY00007956 
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5.4 Individually Identifiable Health Information: This study does involve PHI 
and please see attached combined HIPAA and consent form.  
5.5 Use of radiation: n/a 
5.6 Use of Center for Magnetic Resonance Research: n/a 
6.0 
Data and Specimen Banking 
6.1 
Storage and Access: All study data will be stored on excel spreadsheets in 
University affiliated Box and REDCap. Only the PI and members of the research 
team will have access to the data. 
6.2 
Data: The data from this study will be collected both from Epic and 
directly from the patient. The data collected includes: demographic data, age, 
weight, ASA class, duration of surgery, length of stay in recovery room both 
phase 1 and 2, amount of opioids given intraoperatively and post-operatively, 
non-opioid pain medication, pain score (0-10) at arrival in PACU, satisfaction 
with treatment, PONV, need for supplemental oxygen, OBAS score at time to 
ready to discharge, baseline and 30 minutes post administration six item screener 
score and any adverse events. 
7.0 
Sharing of Results with Participants 
7.1 Study results will not be shared with participants.  Deidentified study data 
may be shared with the peer-reviewed journal.  
8.0 
Study Population 
8.1 Inclusion Criteria: Adult patients aged 18-80 undergoing outpatient 
ambulatory surgery under general anesthesia and who have a pain score of 
4 or greater in the PACU. 
8.2 Exclusion Criteria: Patients under the age of 18, non-english speaking 
patients, cancer surgeries, patients who have allergy or intolerance to the 
study drugs or derivatives, and patients on chronic opioids (defined as daily 
opioids for 3 months or longer) 
8.3 Screening: Patients will be screened by looking at the surgical schedule.  
They will be contacted by the research team ahead of time and have the 
study introduced when they check in on the day or surgery.  They will have 
adequate time to evaluate the study and read through the consent and ask 
questions.   
9.0 
Vulnerable Populations 
9.1 
Vulnerable Populations:  
 
Population / Group 
  


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Children 
Excluded from Participation 
Pregnant women/fetuses/neonates 
Excluded from Participation 
Prisoners 
Excluded from Participation 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Excluded from Participation 
Non-English speakers 
Excluded from Participation 
Those unable to read (illiterate) 
Excluded from Participation 
Employees of the researcher 
Excluded from Participation 
Students of the researcher 
Excluded from Participation 
Undervalued or disenfranchised 
social group 
Excluded from Participation 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Excluded from Participation 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded from Participation 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Excluded from Participation 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Excluded from Participation 


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Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Excluded from Participation 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Excluded from Participation 
 
9.2  Additional Safeguards:  
● 
n/a 
 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented: 200 
11.0 Local Recruitment Methods 
11.1 Recruitment Process: Patients will be recruited from the group of adult 
patients undergoing surgery under general anesthesia at the University of 
Minnesota Ambulatory Surgery Center.  On the day of surgery as soon as 
they are checked in, patients will be informed of a research opportunity by 
a member of the clinical care staff, including the check-in staff, nursing 
staff, or member of the anesthesiology team, and asked if they are 
interested in talking with a member of the research team. A research team 
member will then explain the study and present the consent form. All 
patients will have sufficient time to review the consent and ask questions 
and go over the potential risks of the study with the research team as they 
arrive several hours prior to the procedure. If they decide to participate 
they will be consented and given a copy of the consent form for their 
records.  
11.2 Identification of Potential Participants: Patients will be identified by 
members of the research team by evaluating the surgical schedule.  
Patients known to have opted out of research will not be approached.  
Patients who agree to participate will sign a consent and HIPAA 
authorization.   
11.3 Recruitment Materials: N/a 
11.4 Payment: No payment will be provided to patients.  
12.0 Withdrawal of Participants 


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Ambulatory Surgery Center - STUDY00007956 
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12.1 Withdrawal Circumstances: Subjects who have consented and for some 
reason choose not to participate will be withdrawn and a notation will be 
made in the study records and these people will be considered screen 
failures.  The surgeon may choose to withdraw the patient from the study 
prior to surgery for any medical reason or if they suffer a major life-
threatening adverse event. 
12.2 Withdrawal Procedures: If the patient is withdrawn from study prior to the 
procedure, they will be noted in study records as screen failures. If they 
undergo the procedure and they decide they no longer want to be a part of 
the study or withdrawn by the physician, they will be withdrawn and no 
further data will be collected.  This will also be noted in the study 
documentation. 
12.3 Termination Procedures: If the study is terminated for any reason, or there 
are more than 5% major adverse events the data that is already collected 
will be stored in a secure location only accessible to research personnel on 
this study.  No further data will be collected if the study is terminated. Data 
will only be used for publication if an adequate amount has been collected 
for statistical considerations. Patient research participation duration will be 
on the day of the surgery, therefore if the study is terminated the reason 
would likely not be relevant to previously enrolled patients and they would 
correspondingly not be notified of study termination. If however the 
termination reason is thought to be potentially relevant to previously 
enrolled patients by the Data and Safety Monitoring Committee, they 
would be called and notified by a member of the research team. 
13.0 Risks to Participants 
13.1 Foreseeable Risks: This study has the following risks:  
- 
Life threatening respiratory depression 
- 
Addiction, abuse, and misuse 
- 
Adrenal insufficiency 
- 
Severe hypotension 
- 
Gastrointestinal adverse reactions 
- 
PONV 
- 
Seizures 
These risks all fall within the standard risks of using opioids.  Any intervention being 
provided as a part of this study falls within the standard of care as both medication 
options are within the standard treatments for post-operative pain and are currently used 
as analgesic options at University of MN ASC.   
 
13.2 Reproduction Risks: n/a 
13.3 Risks to Others: n/a 


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14.0 Potential Benefits to Participants 
14.1 Potential Benefits: The potential benefits of participating in this study 
include reduced pain and shortened recovery room stay.  
15.0 Statistical Considerations 
15.1 Data Analysis Plan: We plan to collect our data using REDCap and excel 
which will be maintained in Box.  When the study is completed and ready 
for statistical analysis the data will be shared with our staff statistician. 
15.2 Power Analysis: No prior studies have been done. Therefore, a power 
analysis was done using recovery room time data collected here at the ASC 
from July to September 2019 for similar general anesthesia cases that we 
would expect to enroll in this study. These power calculations found that 
we would need to enroll 33 per group to reach a 0.95 power for an 
absolute time difference of 30 minutes. 
15.3 Statistical Analysis: This study will be analyzed by our staff biostatistician.  
The statistician will be provided the protocol so they are able to analyze for 
primary and secondary objectives.  
15.4 Data Integrity: All patients will be assigned a unique patient identifier.  The 
data will be sent to the statistician will be deidentified.  
16.0 Confidentiality 
16.1 Data Security: All paper documents and consent forms will be stored in a 
locked cabinet in the anesthesia research office in B573 Mayo.  All study 
data will be stored electronically in Box and REDCap. Only the PI and 
members of the research team will have access to the data.  
17.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
17.1 Data Integrity Monitoring.  
● 
The PI, co-investigators, and research assistants will all have access to 
the study data stored in the University’s Box storage system. All the 
research assistants have experience collecting pain scores and other 
relevant study information. The PI of the study will periodically 
review the study data to ensure accuracy and completeness of study 
data. 
17.2 Data Safety Monitoring.  
The Department of Anesthesiology has established a Data and Safety Monitoring 
Committee consisting of several staff anesthesiologists which include persons 
who are board certified as pain specialists. Data will be transmitted in box to 
persons on the board on a monthly basis for review.  If there are patterns of 
adverse events, the board will meet as needed and provide recommendations. 


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All safety data will be collected on a case report form and transferred into an 
excel spread sheet that will be stored in box. 
The data will be reviewed on a regular basis (weekly) by the PI and research 
staff.  If there are consistent complications noted a meeting will be convened by 
the DSMB for recommendations. 
The statistical tests for analyzing the safety data to determine whether harm is 
occurring. 
The statistician uses R or SAS for analysis.  Most likely a regression analysis will 
be performed to see which event is most likely the contributor for the 
complications.  Also, a chi-square analysis can be performed.  All is very 
dependent on data variability. 
A fatal or serious adverse event that is attributable to either the delivery or the 
study medication itself. 
18.0 Provisions to Protect the Privacy Interests of Participants 
18.1 Protecting Privacy: Patients will be asked if this is a good time to answer 
questions.  All patients will have the right to refuse to answer questions 
when asked.  All data will be deidentified when entered and stored using a 
unique study identifier.  
18.2 Access to Participants: All patients will be required to sign a combined 
HIPAA and study consent that states their privacy of the data being 
collected. It also describes that all data is deidentified and stored in a 
secure database.  They will be informed that data is stored and reviewed in 
box which is HIPAA compliant and that only study personnel have access.  
19.0 Compensation for Research-Related Injury 
19.1 Compensation for Research-Related Injury: In the event that this research 
activity results in an injury, treatment will be available, including first aid, 
emergency treatment, and follow-up care as needed.  Care for such injuries 
will be billed in the ordinary manner, to the patient and/or insurance 
company.  
19.2 Contract Language: N/A. 
20.0 Consent Process 
20.1 Consent Process (when consent will be obtained):  
● 
Consent Process (when consent will be obtained): Patients will be 
identified in the pre-operative time period by the research team on 
the day of surgery.  As soon as they enter their pre-operative room, 
an anesthesiologist will mention the study and ask permission for a 
research staff member to discuss it further if they are interested. If an 
anesthesiologist is not available when they are roomed, check-in or 


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nursing staff will mention the study and ask the patient if a research 
member can discuss it with them further.  If they are interested they 
will meet a research staff member and be presented with a combined 
Health and Insurance Portability and Accountability Act (HIPAA) and 
study consent form.  The patient will review the form with a member 
of the research team.  Subjects will be reminded that participation is 
completely voluntary, and that they may stop participation at any 
time without question or penalty.  The research team will answer any 
questions that the subjects may have about the study. They will also 
be notified that we will ensure they have the time to contact their 
insurance regarding coverage concerns if they wish. If the patient 
decides to participate, they will be asked to sign the consent and 
HIPAA form.  One copy will be saved for study records, and the 
subject will be provided with a copy of the forms for their own 
records.  
20.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained): N/A 
20.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained): N/A 
20.4 Non-English Speaking Participants: N/A 
20.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): N/A 
20.6 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: N/A 
20.7 Adults Unable to Consent: 
● 
Permission: N/A 
● 
Assent: N/A 
● 
Dissent: N/A  
21.0 Setting 
21.1 Research Sites: Patients will be consented and post-surgical care will take 
place at the M Health Fairview ASC.   
21.2 International Research: N/A 
 
22.0 Multi-Site Research 
● 
N/a 
23.0 Resources Available 
23.1 Resources Available:  


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Research assistants are available to aid in consent and data acquisition. All 
research assistants will be familiar with the study protocol and have experience 
working with similar studies. 
We plan to enroll 66 subjects.  To accomplish this we will need to screen 200 
subjects (assuming nearly 70% of patients will not have moderate to severe pain 
in PACU) and enroll 75 (assuming roughly around 10% drop out/screen fail) to 
reach this target population.  This center performs approximately 50 qualifying 
surgical procedures weekly and therefore this should be able to be completed in 4 
weeks.  
Once we reach 33 patients in each group, enrollment and data collection will be 
completed at this time.  Statistical Analysis will take approximately one month to 
complete. 
All procedures will be performed in the clinical facilities at the M Health 
Fairview Clinics and Surgery Center.  Data storage and analysis will be done 
using IT equipment which is available at the Research Office B573 Mayo. 
In the event that this research activity results in an injury, treatment will be 
available, including first aid, emergency treatment and follow-up care as needed. 
Care for such injuries will be billed in the ordinary manner, to the patient and/or 
insurance company.  
All study personnel will be adequately trained by the Principle Investigator on the 
study protocol and study conduct.  A log will be maintained to track which 
personnel are trained.  A delegation of authority log will also be maintained to 
track which personnel are responsible for specific duties. 
 
 
24.0 References 
1. Hutchins JL et al An Open-Label study of sufentanil sublingual tablet 30 mcg in 
patients with postoperative pain. Pain Med 2017 
2. Minkowitz HS et al. Sufentanil sublingual tablet 30 mcg for the management of 
pain following abdominal surgery: A randomized, placebo-controlled phase-3 
study. Pain Pract. 2017;17:848-858.