Clinical trial NCT03872843
Conditions: Kidney Stone
Keywords: Ureteroscopy Opioid Non-Opioid Stent Placement Nephrolithiasis
Sponsor: Wake Forest University Health Sciences
Start date: 2019-09-19; Completion date: 2020-02-26
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare how well two medications work to control post-operative pain.

Detailed description:
This will be a randomized double blinded control trial with subjects randomized to either opioid group (Norco 5-325 milligram) or a non-opioid group (Ibuprofen 400 milligram). Subjects with a renal stones who are consented for a ureteroscopy will be eligible for the study. Subjects eligible for the study will have a discussion with the study team member about treatment options. Subjects can either elect not to be in the study and actively choose which treatment is preferable, or the subject can choose to enter the study and be randomized to one of these treatment arms. The ureteroscopy will be performed using standard of care instruments and techniques. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. Post operatively; investigators plan to discharge all subjects home from the recovery unit. All subjects will be seen one week after surgery for follow up, questioner filling and stent removal.

Arms: arm 1: This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement. arm 2: This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.
Interventions: intervention 1: Norco 5milligram-325milligram Tablet intervention 2: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Intervention descriptions: intervention 1: Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later. intervention 2: Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later.

Protocol documents:
Prot_SAP_001.pdf: 
Protocol version: 2 
Updated 9-9-19 
1 
Study Title: A prospective double blind randomized control trial comparing 
the standard-of-care (SOC) prescription analgesic to an over-the-counter 
(OTC) analgesic protocol in managing postoperative pain after ureteroscopy 
with stent placement 
 
NCT: NCT03872843 
 
Date:  9.9.19 
 
Principal Investigator: Jorge Gutierrez-Aceves 
 
Co-investigator(s): Ilan Klein, Taylor peak, Teresa Biles  
 
Sponsor or funding source: Departmental 
 
Background, Rationale and Context 
Ureteral stent placement is one of the most frequent procedures that we as urologists perform, 
especially in the field of stones in the urinary tract. The term "stent" refers to a thin tube that we 
place within the lumen of the ureter to maintain its patency, permit healing or relieve an 
obstruction. The most common type of stent we use is the “double J stent,” which was described 
in 1978 by Finney and has a proximal curl that is situated in the renal pelvis and a distal curl that 
is situated in the urinary bladder to keep the stent in place1.  
 
The current AUA/Society of Endourology guidelines published in 2016 state that it is reasonable 
to not stent patients after an ureteroscopy (URS) if they do not have a suspected ureteral injury, 
have no evidence of stricture or anatomic abnormality, have a normal contralateral kidney and 
normal renal function, and are not anticipated to need a second procedure2. But, truth be told, the 
majority of patients that undergo a URS end up with having a stent placed.  
Despite their great value and common use in the field of urology, stents have several common 
side effects. These include infection, encrustation necessitating replacement, hematuria, stent 
pain and bothersome lower urinary tract symptoms (LUTS), which are estimated to affect at least 
80% of patients who have an indwelling ureteral stent placed3. These symptoms include 
frequency, urgency, dysuria, incomplete emptying, flank pain, suprapubic pain, and 
incontinence. 
 
There are several mechanisms that have been postulated as the cause of stent-related pain 
and voiding symptoms. The stent-related flank pain and renal colic can be secondary 
to reflux of urine through the stent during voiding, when intravesical pressures increase with 
contraction that transmits the increased pressures to the renal collecting system and ultimately 
resulting in flank pain4. There is also the issue of stent movement with patient's activity and stent 
position that are thought to be additional sources of pain and lower urinary tract symptoms due to 
direct irritation of the bladder mucosa5,6.  
 
One of the tools that has helped to standardize research on stent related complications is the 
ureteral stent symptoms questionnaire (USSQ) that Joshi and colleagues described in 20037. This 
questionnaire consists of 38 items split into 6 sections: pain, voiding symptoms, work 
performance, sexual matters, overall general health, and additional problems.  


Protocol version: 2 
Updated 9-9-19 
2 
 
Several medications have been tried and studied in an attempt decrease stent-related symptoms 
after placement. Nonsteroidal anti- inflammatory drugs (NSAIDs) and narcotic/opioid analgesics 
can be helpful for the pain, but do not have any impact on the voiding symptoms, for which the 
primary medications used are alpha-blockers and antimuscarinic and the AUA/Society of 
Endourology Guidelines lists providing these medications to patients to help reduce stent 
discomfort as a moderate recommendation with level B evidence2. 
In the United States, there is a known raging opioid abuse epidemic fueled by prescription 
medications and resulting in significant strain on our healthcare system. There is increasing 
evidence that prescribers are at least partly responsible for the opioid crisis because of 
overprescribing, in part due to the concern that uncontrolled pain after surgical procedures will 
result in poor patient satisfaction and increased workload for ancillary staff.8  
Currently, there is a paucity of literature on analgesic requirements after URS for nephrolithiasis. 
It is critical that we as urologists and prescribers find a way to stop the needless overprescribing 
while still treating postoperative pain appropriately. 
As such, efforts have recently begun to implement non-opioid protocols for outpatient urologic 
surgeries, but the majority of them retrospective.9,10 
 
Our study objective is to evaluate the feasibility of a narcotic-free protocol in the management of 
postoperative pain after URS with stent placement and compare it to the current standard of care  
in our practice that does include opioids.  
 
In our study, we propose to randomize 100 patients that undergo an outpatient URS for renal 
stones with stent placement into the two arms once being discharged, in a double blinded 
fashion, either with ibuprofen 400mg or Norco 5/325mg for pain management. Both being 
scheduled QID prn pattern until the stent will be removed in our clinic a week later. This type of 
study has never been performed before in the United States and could potentially change 
treatment patterns for this common problem.   
 
Objectives 
1. Primary Objective – To determine that a non -narcotic/opioid protocol for pain 
management can be implemented for URS outpatient stented patient population common 
to the United States.  
2. Secondary Objective – To compare number of visits to the ED for postoperative 
genitourinary symptoms and pain, monitor number of telephone calls to the clinic, and 
requests for prescription pain medication refills of opioid Vs. non-opioids discharged 
patients.  
 
Methods and Measures 
 
Design 
This will be a randomized double blinded control trial with subjects randomized to either the 
WFBH Urology practice’s  standard of care pain-relief narcotic/opioid group (Norco 5-325 mg) 
or an available over-the-counter non-opioid group (Ibuprofen 400 mg).  Patients will be enrolled 
who are seen in the Urology Clinic at 140 Charlois Blvd.  Those subjects with a renal stones who 
are consented for a ureteroscopy will be eligible for the study. Subjects eligible for the study will 
have a discussion with the study team member about their treatment options.  They will be told 


Protocol version: 2 
Updated 9-9-19 
3 
that the standard of care analgesic that is provided to patients undergoing ureteroscopy with stent 
placement is Norco.  They will be informed that if they choose to take part in the study they will 
be randomized to receive the SOC medication (Norco), or they may receive OTC Ibuprofen 
which is a nonsteroidal anti-inflammatory medication.  They can either elect not to be in the 
study and actively choose which treatment they would like, or they can choose to enter the study 
and be randomized to one of these treatment arms.   
 
If the subject chooses to be enrolled in the study, they will sign the consent form for 
participation, as well as surgical consent form for URS. Randomization will be performed by the 
Investigational Drug Study pharmacy on the 10th floor of the Cancer Center and will occur prior 
to the surgical date chosen by the surgeon and the patient.  Randomization will be performed 
using a random number generator.  
 
The URS will be performed using standard of care instruments and techniques.  No changes to 
operative technique will be performed for subjects in the study vs regular patients undergoing the 
same procedure. Post operatively; we plan to discharge all subjects home from the recovery unit.  
Hospital pharmacy will coat and prepare the generic medication and distribute the medication to 
the patients before they are discharged from the outpatient PACU.  
  
All subjects will be seen one week after surgery for follow up, questioner filling and stent 
removal. At that point the remaining study medication will be returned as will information about 
ED visits and pain medication refilled will be collected as well.   
 
Setting 
Surgery will be performed at an academic medical center.  All follow up care will be 
performed at the urology outpatient clinic. 
 
Subject selection criteria 
 Inclusion Criteria 
Ureteroscopy performed for renal stones 
Age over 18 years  
Two kidneys 
 
Exclusion Criteria 
Solitary Kidney 
Poor kidney function (GFR<30) 
Allergy to either Ibuprofen or Norco 
Pelvic Kidney 
 Sample Size 
100 Patients with the plan to enroll 50 patients in each group.   
 
Interventions and Interactions  
All subjects enrolled in the study will be randomized to either narcotic/opioid or non-opioid 
management of postoperative pain after their stones treatment. The date of treatment will be 
decided between the subject and the treating surgeon.  All treatments will be performed using the 
standard of care and will be performed in the same fashion as procedures for patients not 
enrolled in the study. There is no modification of the techniques used to remove the stones.   


Protocol version: 2 
Updated 9-9-19 
4 
 
Post operatively, we plan to discharge all subjects home from the recovery unit with their 
designated coated pain medication supply for 7 days as well as usual scripts for alpha blockers 
and anti-muscarinic medication usually dispensed for LUTS.  All subjects will be seen one week 
after surgery for follow up, collection of the remaining study medication, review of ED visits and 
pain medication refills, questioner filling and stent removal. 
 
Outcome Measure(s) 
The primary outcome will be the amount of pain medication used in each treatment arm and the 
need for additional pain medication and refills. Secondary outcomes will be needed ED visits, 
phone calls to clinic and symptoms evaluation using a validated questioner filled during their 
clinic visit.   
 
Analytical Plan 
Results will be analyzed initially using descriptive statistics.  Comparison between groups will 
be done using chi square tests for proportions, and t-tests or ANOVA procedures for continuous 
variables.  Regression analysis will be performed to identify independent outcome predictors.  
Other inferential statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
There will be no active recruitment of subjects.  All subjects will be identified based on referrals 
to the urology outpatient clinic.  All patients with renal stones appropriate for a ureteroscopy will 
be eligible for the study.   
 
Subject confidentially will be maintained by keeping all physical consent forms in a locked 
drawer in a locked office in Wattlington Hall.  All electronic data will be maintained on a 
password secured computer in the hospital.  This study does not require the transmission of an 
PHI to any entity outside the study team. No record of the study will be placed in the medical 
record so nobody outside the study team will know that the patient will be enrolled in the study.  
 
All data and documents related to the study will be destroyed 36 months after completion of the 
study. 
 
Informed Consent 
 
Signed informed consent will be obtained from each subject.  Consent will be obtained by a member of 
the study team.  Consent will be obtained during the initial clinic visit at the urology outpatient clinic.  
 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form.  Any collected 
patient identifying information corresponding to the unique study identifier will be maintained on a 
linkage file, store separately from the data.  The linkage file will be kept secure, with access limited to 


Protocol version: 2 
Updated 9-9-19 
5 
designated study personnel.  Following data collection subject identifying information will be destroyed 
after 36 months, consistent with data validation and study design, producing an anonymous analytical 
data set.  Data access will be limited to study staff.  Data and records will be kept locked and secured, 
with any computer data password protected.  No reference to any individual participant will appear in 
reports, presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes will 
be promptly reported by the principal investigator or designated member of the research team to the IRB 
and sponsor or appropriate government agency if appropriate. 
 
 
 
 
References 
1. Finney RP. Experience with new double J ureteral catheter stent. J Urol. 1978 Dec;120(6):678-
681. 
2. Assimos D, et al. Surgical management of stones: American urological 
association/endourological society guideline. J Urol. 2016;196(4):1161–9 
3. Joshi HB, Okeke A, Newns N, Keeley FX Jr, Timoney AG. Characterization of urinary 
symptoms in patients with ureteral stents. Urology. 2002 Apr;59(4):511-516. 
4. Mosli HA, Farsi HMA, al-Zimaity MF, Saleh TR, al-Zamzami MM. Vesicoureteral reflux in 
patients with double pigtail stents. J Urol. 1991;146(4):966–969. 
5. Chew BH, Knudsen BE, Nott L, Pautler SE, Razvi H, Amann J, et al. Pilot study of ureteral 
movement in stented patients: first step in understanding dynamic ureteral anatomy to improve 
stent comfort. J Endourol. 2007;21(9):1069–75. 
6. Al-Kandari AM, et al. Effects of proximal and distal ends of double-J ureteral stent position on 
postprocedural symptoms and quality of life: a randomized clinical trial. J Endourol. 2007;21(7): 
698–702. 
7. Joshi HB, et al. Ureteral stent symptom questionnaire: development and validation of a 
multidimensional quality of life measure. J Urol. 2003;169(3):1060–1064. 
8. Theisen K, Jacobs B, Macleod L, Davies B. The United States opioid epidemic: a review of the 
surgeon's contribution to it and health policy initiatives.  BJU Int. 2018 Nov;122(5):754-759. 
9. Large T, Heiman J, Ross A, Anderson B, Krambeck A. Initial Experience with Narcotic-Free 
Ureteroscopy: A Feasibility Analysis. J Endourol. 2018 Oct;32(10):907-911. 
10. Sobel DW, Cisu T, Barclay T, Pham A, Callas P, Sternberg K. A Retrospective Review 
Demonstrating the Feasibility of Discharging Patients Without Opioids After Ureteroscopy and 
Ureteral Stent Placement. J Endourol. 2018 Nov;32(11):1044-1049. 
 
 
Appendix 
1. Consent form  
2. Ureteral stent symptoms questionnaire (USSQ) 
 

ICF_000.pdf: 
Page 1 of 8
Adult Consent Form
SOC pain vs OTC protocol
Version 4 5-1-20
Department/Section of Urology
A Prospective Double Blind Randomized Control Trial Comparing the 
Standard-Of-Care (SOC) Prescription Analgesic to an Over-The-Counter 
(OTC) Analgesic Protocol In Managing Postoperative Pain After 
Ureteroscopy with Stent Placement
Informed Consent Form to Participate in Research
Jorge Gutierrez-Aceves, MD Principal Investigator
SUMMARY
You are invited to participate in a research pilot study. The purpose of this research is to 
determine if Over-The-Counter analgesia (pain relief medicine) works the same at relieving pain 
as the Standard of Care narcotic based analgesia that we normally prescribe for stent colic after 
ureteroscopy.  You are invited to be in this study because you will be undergoing ureteroscopy. 
Your participation in this research will involve two clinic visits and last about 1 hour in total. 
You will be undergoing ureteroscopy.  Your participation in the study involves you taking a pain 
medication and completing a survey at clinic visit post operatively. You will track your use of 
the randomized analgesic prescribed to you the time between procedure and clinic visits. 
Randomized means that the choice of the analgesic given to you will be decided randomly, like 
by flipping a coin. All research studies involve some risks.  A risk of this study that you should 
be aware of is not having your pain relieved adequately from the OTC medication, as well as, the 
unlikely possibility of becoming dependent upon the SOC narcotic medication.  There is the 
possibility that you may benefit from participation in this study and that your pain will be well 
controlled from either medication.  
Your participation in this study is voluntary.  You do not have to participate in this study if you 
do not want to.  There may be other choices available to you.  Some other choices may include 
deciding on the postoperative analgesia that you will be prescribed.  You will not lose any 
services, benefits, or rights you would normally have if you choose not to participate. 
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
study. The person in charge of this study is Dr. Jorge Gutierrez. If you have questions, 
suggestions, or concerns regarding this study or you want to withdraw from the study his contact 
information is:
. 
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Research Subject 
Advocate at Wake Forest at 
.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021


Page 2 of 8
Adult Consent Form
SOC pain vs OTC protocol
Version 4 5-1-20
INTRODUCTION
You are invited to be in a research pilot study. Research studies are designed to gain scientific 
knowledge that may help other people in the future. You are being asked to take part in this 
study because you have kidney stones. Your participation is voluntary. Please take your time in 
making your decision as to whether or not you wish to participate. Ask your study doctor or the 
study staff to explain any words or information contained in this informed consent document that 
you do not understand. You may also discuss the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to compare how well two medications work to control post-
operative pain.  One of the medications is normally prescribed for pain following ureteroscopy. 
The other medication is a common over-the-counter pain reliever.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
Approximately 100 people at one research site will take part in this study. 
WHAT IS INVOLVED IN THE STUDY?
You will be randomized into one of two study groups described below. Randomization means 
that you are put into a group by chance. It is like flipping a coin. You will have an equal chance 
of being placed in each group.
During this study, you will be placed into a group that either is provided with the standard of 
care pain medication called Norco (a narcotic pain medication) or you will receive Ibuprofen (a 
non-steroidal pain medication that is available without a prescription) for post-operative pain 
management . Neither you nor the investigator or other people involved in the study will know 
which medication. you are receiving. This is done so that a fair evaluation of results can be 
made. This information is available to the researchers if needed in an emergency.
No matter which medication you will receive, you will be evaluated in a standard fashion with 
blood work to measure your blood counts, electrolytes and kidney function as well as a urine 
culture.  You will need to see the anesthesiologist prior to surgery to evaluate your heart and 
lungs for surgery.  After surgery, we plan to send you home after spending about an hour in the 
surgery recovery room.  You will then follow up in 1 week for removal of the stent in the office. 
You will be called at home post-operatively to assure adequate pain control. On return to the 
office, you will fill out a survey assessing pain control
Everyone in the study will undergo ureteroscopy. Ureteroscopy is a surgery where you will go to 
sleep in the operating room, and a camera will be placed into the bladder, then up into the kidney 
where your stone is located.  Using a laser, the stone will be lasered into small pieces.  The 
pieces will be removed using a small basket, and a small tube called a stent will be placed on the 
inside to drain the kidney.  You will come back to clinic in about 1 week to have the stent 
removed.  You will then follow up in about a month with a CT scan to check for any left over 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021


Page 3 of 8
Adult Consent Form
SOC pain vs OTC protocol
Version 4 5-1-20
stones.   
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for about 1 week until your follow up in the urology clinic.  
You can stop participating at any time. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. Sudden withdrawal from the study could mean that you will have residual 
stones which could cause bleeding, pain, infection, kidney blockage, or kidney failure. 
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. 
There are also risks and side effects associated with Ibuprofen which include
-stomach pain, heartburn, nausea, vomiting, diarrhea, constipation, kidney damage, liver damage
 
There are also risks and side effects associated with Norco which include
- stomach pain, heartburn, nausea, vomiting, diarrhea, constipation, liver damage, slow 
breathing, tiny pupils, loss of consciousness, and opioid addiction/dependence
This study is comparing two approved methods for treating pain.  You will be randomly assigned 
to one of the two groups. It is possible that one treatment group may have a better response than 
the other. Therefore, there is a risk that you may be assigned to a group that does not perform as 
well as its comparison and your pain relief may not be adequate.
In addition, there is a slight risk of a breach of confidentiality.  We will do our best to protect 
your confidential information.  There also may be other side effects that we cannot predict. You 
should tell the research staff about all the medications, vitamins and supplements you take and 
any medical conditions you have. This may help avoid side effects, interactions and other risks.
Taking part in this research study may involve providing information that you consider 
confidential or private.  Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
Reproductive Risks and other Issues to Participating in Research
Due to unknown risks and potential harm to the unborn fetus, sexually active women of 
childbearing potential must use a reliable method of birth control while participating in this 
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, 
intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with 
confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, 
although less reliable, method involves the careful use of condoms and spermicidal foam or gel 
and/or a cervical cap or sponge. We encourage you to discuss this issue further with your 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021


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Adult Consent Form
SOC pain vs OTC protocol
Version 4 5-1-20
physicians if you have any questions.
Pregnant women are excluded from participation in this study. Because some methods of birth 
control are not 100% reliable, a pregnancy test is required at least 10 days from your last normal 
menstrual period, if you are a sexually active woman of childbearing potential.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
You are not expected to receive any direct benefit from taking part in this research study. We 
hope the information learned from this study will benefit other people in the future.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to your doctor about all 
the choices you have. Instead of being in this study, you have the option of choosing a surgical or 
non-surgical treatment option of your choice.  These options include observation with medical 
expulsive therapy, ureteroscopy, mini percutaneous nephrolithotomy or shock wave lithotripsy. 
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any new information we collect from you and/or information we get from 
your medical records about your health or behaviors is considered Protected Health Information. 
The information we will collect for this research study includes: 
- age, medical comorbidities, body mass index, imaging results 
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
and may be used to help treat you, arrange payment for your care, or assist with Medical Center 
operations. 
We will make every effort to keep your Protected Health Information private. We will store 
records of your Protected Health Information in a cabinet in a locked office or on a password 
protected computer. 
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board; representatives of Wake Forest University Health 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021


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SOC pain vs OTC protocol
Version 4 5-1-20
Sciences and North Carolina Baptist Hospital; representatives from government agencies such as 
the Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), 
the Department of Health and Human Services (DHHS) and similar agencies in other countries.  
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs or 
recorded media which are identifiable.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for at least six years after the study is finished. At that time, any 
research information not already in your medical record will either be destroyed or it will be de-
identified.  Any research information entered into your medical record will be kept for as long as 
your medical record is kept by the Medical Center. You will not be able to obtain a copy of your 
Protected Health Information in the research records until all activities in the study are 
completely finished. 
You can tell Dr. Jorge Gutierrez-Aceves that you want to take away your permission to use and 
share your Protected Health Information at any time by sending a letter to this address:
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form, you give us permission to use your Protected Health Information for this 
study.
If you choose to participate in this study, your medical record at Wake Forest University Baptist 
Medical Center will indicate that you are enrolled in a clinical trial.  Information about the 
research and any medications or devices you are being given as a participant may also be 
included in your medical record.  This part of the medical record will only be available to people 
who have authorized access to your medical record.  If you are not a patient at this Medical 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021


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SOC pain vs OTC protocol
Version 4 5-1-20
Center, a medical record will be created for you anyway to ensure that this important information 
is available to doctors in case of an emergency.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This website will not include information that can identify you.  At most, the 
website will include a summary of the results.  You can search this Web site at any time.
Laboratory test results and other medical reports created as a result of your participation in the 
research study may be entered into the computer systems of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital.  These will be kept secure, with access to this 
information limited to individuals with proper authority, but who may not be directly involved 
with this research study.
WHAT ARE THE COSTS?
There will be no added costs to your care for the medications.  All procedures will be standard of 
care.  
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this study.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by Wake Forest University Health Science. The sponsor is 
providing money or other support to Wake Forest University Health Sciences to help conduct 
this study. 
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A 
RESULT OF PARTICIPATING IN THIS STUDY?
Should you experience a physical injury or illness as a direct result of your participation in this 
study, Wake Forest University School of Medicine maintains limited research insurance 
coverage for the usual and customary medical fees for reasonable and necessary treatment of 
such injuries or illnesses. To the extent research insurance coverage is available under this policy 
the reasonable costs of these necessary medical services will be paid, up to a maximum of 
$25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this 
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of 
$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these 
medical services or to provide any other compensation for such injury or illness. Additional 
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management, at 
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care.  This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021


Page 7 of 8
Adult Consent Form
SOC pain vs OTC protocol
Version 4 5-1-20
You do not give up any legal rights as a research participant by signing this consent form. For 
more information on medical treatment for research related injuries or to report a study related 
illness, adverse event, or injury you should call Dr. Jorge Gutierrez-Aceves at 
. 
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because it is in your best medical interest, your condition has changed 
or worsened, you failed to follow instructions, or because the entire study has been stopped. 
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
Identifiers might be removed from your identifiable private information or identifiable 
biospecimens and after such removal, your information or biospecimens could be used for future 
research studies or distributed to another investigator for future research studies without 
additional informed consent from you or your legally authorized representative
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, Dr. Jorge Gutierrez-Aceves at 
.
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
.
You will be given a copy of this signed consent form. 
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_____________________________
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021


Page 8 of 8
Adult Consent Form
SOC pain vs OTC protocol
Version 4 5-1-20
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00056720
Meeting Date Approved 4/29/2020          
Version Valid Until: 4/14/2021