Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study
Phase: PHASE4
Conditions: Supracondylar Humerus Fracture
Sponsor: Children's Mercy Hospital Kansas City

Protocol Document:  
 
Nonopioid versus opioid outpatient pain management following surgical 
ﬁxation of Gartland Type III supracondylar humerus fracture in children: a 
prospective, randomized trial 
 
NCT06187584 
 
Last approval date: 02/04/2025 
 
 

Prospective SCHF Post-Op Pain Management Study 
IRB#: 00000286 
 
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PROTOCOL TITLE: 
Nonopioid versus opioid outpatient pain management following surgical fixation of 
Gartland Type III supracondylar humerus fractures in children: A prospective, 
randomized study  
PRINCIPAL INVESTIGATOR: 
Co-Principal Investigators: 
Dr. Caleb Grote MD, PhD 
Department of Orthopaedic Surgery 
Children’s Mercy Hospitals and Clinics 
cwgrote@cmh.edu  
816-458-6021 
 
Dr. Lisa Berglund, MD 
Department of Orthopaedic Surgery 
Children’s Mercy Hospitals and Clinics 
lberglund@cmh.edu  
816-234-3693 
 
Co-Investigator: 
Dr. Jonathan Warren, MD 
Department of Orthopaedic Surgery 
Children’s Mercy Hospitals and Clinics 
 
jrwarren@cmh.edu 
 
816-234-3693 
 
 
George Thomas, BS 
 
George Washington University 
 
gmthomas1@cmh.edu 
 
816-234-3693 
 
 
Consultants: 
 
Dr. Daniel Millspaugh, MD 
Director, Comprehensive Pain Management Program 
Contract Physician, Departments of Anesthesiology and Pain Management 
Children’s Mercy Hospitals and Clinics 
dmillspaugh@cmh.edu    
816-234-1590 
 
David D. Williams, MPH 
Biostatistician 
Division of Health Services and Outcomes Research 
Children’s Mercy Kansas City 
ddwilliams@cmh.edu 
816-302-9942 
 

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Research Assistant: 
 
Research Coordinator: 
Trina Regis 
Research Core Orthopaedic Surgery 
tregis@cmh.edu 
(816) 731-7276 ext. 47276 
 
 
VERSION NUMBER/DATE: 
Protocol Version:  (3.0)                          Protocol Date: 09.16.2021 
REVISION HISTORY 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
3/8/2019 
IRB requested changes 
yes 
2 
6/13/2019 
Adding advertisement for CMH staff 
no 
3 
9.16.21 
Adding KUMC Resident to study. Tanner 
Campbell, MD 
yes 
4 
10.25.22 
Adding Dr. Jonathan Warren and George 
Thomas to the study 
Updating protocol to add Twilio for contacting 
families 
yes 
5 
12.16.2024 
Adding Dr. Caleb Grote MD, PhD as Primary 
Investigator 
No 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives ................................................................................................................ 5 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Endpoints ....................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 6 
6.0 
Procedures Involved................................................................................................. 7 
7.0 
Data and Specimen Banking .................................................................................... 8 
8.0 
Genetic Analysis Information .................................................................................. 8 
9.0 
Sharing of Results with Subjects ............................................................................. 8 
10.0 Study Timelines ....................................................................................................... 8 
11.0 Inclusion and Exclusion Criteria .............................................................................. 8 
12.0 Vulnerable Populations ............................................................................................ 9 
13.0 Local Number of Subjects ....................................................................................... 9 
14.0 Screening and Recruitment Methods ..................................................................... 10 
15.0 Reimbursement, Payment and Tangible Property provided to subjects ................ 10 
16.0 Withdrawal of Subjects .......................................................................................... 10 
17.0 Risks to Subjects .................................................................................................... 10 
18.0 Potential Benefits to Subjects ................................................................................ 11 

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19.0 Data Management and Confidentiality .................................................................. 11 
20.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 13 
21.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 13 
22.0 Compensation for Research-Related Injury ........................................................... 13 
23.0 Economic Burden to Subjects ................................................................................ 13 
24.0 Permission/Assent/Consent Process ...................................................................... 14 
25.0 Process to Document Permission/Assent/Consent................................................. 14 
26.0 Setting .................................................................................................................... 14 
27.0 Resources Available............................................................................................... 15 
28.0 Multi-Site Research ............................................................................................... 15 
29.0 International Research ........................................................................................... 15 
30.0 References .............................................................................................................. 15 
 
 
 

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1.0 
Study Summary 
Study Title 
Nonopioid versus opioid outpatient pain management 
following surgical treatment of Gartland type III 
supracondylar humerus fractures in children: A prospective, 
randomized study 
Study Design 
Prospective, two-arm, parallel-group, randomized study 
conducted at a single center 
Primary Objective 
To determine if nonopioid analgesic regimens are non-
inferior to opioid analgesic regimens in managing 
postoperative pain in the outpatient period following surgical 
treatment of Gartland type III supracondylar humerus 
fractures in children. 
Secondary 
Objective(s) 
To describe outpatient pain management following surgical 
treatment of Gartland type III supracondylar humerus 
fractures in children. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Control Group (opioid group):  
Hydrocodone/acetaminophen 0.15mg/kg PO q6 
hours PRN with ibuprofen 10mg/kg PO q6 hours 
PRN 
 
Experimental Group (nonopioid group):  
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 
10mg/kg PO q6 hours 
IND/IDE #  
N/A 
Study Population 
Patients 48-119 months of age presenting to Children’s 
Mercy Hospital Adele Hall campus for surgical treatment of 
a Gartland type III supracondylar humerus fracture. 
Sample Size 
160 (up to 300 to be pre-screened) 
Study Duration for 
Individual 
Participants 
Study participation starts at the time of presentation at 
Children’s Mercy Hospital Adele Hall campus and ends at 
the third follow-up visit. Study duration for individual 
participants will be approximately 6-12 weeks.  
Study Specific 
Abbreviations/ 
Definitions  
SCHF: supracondylar humerus fracture 
O: Opioid group 
NO: Nonopioid group 
 
 

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2.0 
Objectives 
Our primary objective is to determine if nonopioid analgesic regimens are non-inferior to 
opioid analgesic regimens in the management of post-operative pain in the outpatient 
period following surgical fixation of Gartland type III SCHFs in children.  
 
We hypothesize that there is no difference in daily pain levels for nonopioid analgesic 
regimens compared to opioid analgesic regimens in management of post-operative pain 
in the outpatient period following surgical fixation of Gartland type III supracondylar 
humerus fracture in children. 
3.0 
Background 
Pain is variably managed in pediatric populations, particularly in the postoperative 
outpatient setting.1,3,5,6   The lack of data describing and supporting the safety and 
efficacy of the use of analgesic drugs in children is a major contributor to this problem.   
Postoperative prescription opioids have been associated with high rates of morbidity and 
mortality in children and identified as a pathway to future opioid abuse.7-9  With 
increasing public awareness regarding these issues surrounding opioid use and no 
evidence to support superior treatment outcomes in children with the use of opioids, there 
is a pressing need for data to guide healthcare providers in choosing analgesic drugs to 
treat postoperative pain in pediatric patients.5 
 
Prior studies have evaluated the use of nonopioid versus opioid analgesic drugs in the 
outpatient setting following pediatric ambulatory surgery.1,3,5  These studies found 
nonopioid analgesics, such as acetaminophen and ibuprofen, to be as equally effective as 
opioid analgesics, including morphine, codeine and oxycodone.  Further, the use of 
nonopioid analgesics was associated with significantly fewer side effects.1,3,5  These 
findings imply that nonopioid analgesics may be a superior initial therapy following 
ambulatory surgery.  
 
However, no study has evaluated the use of nonopioid versus opioid analgesic regimens 
in the outpatient setting following surgical fixation of supracondylar humerus fractures 
(SCHFs).  SCHFs are the second most common fracture in children, often requiring 
urgent surgical intervention.10  Despite their frequency, there is no standard for 
postoperative outpatient pain management in the treatment of these injuries.   
 
Almost all SCHFs can be described according to the Gartland classification.  The 
Gartland classification delineates three types of SCHFs.  Gartland type I fractures are 
nondisplaced and do not require surgical intervention, while Gartland type II fractures are 
angulated, but maintain an intact posterior cortex.  These may or may not require surgical 
intervention.  However, Gartland type III fractures are completely displaced with no 
posterior cortical contact and require surgical intervention with either closed reduction 
and percutaneous pinning (CRPP) or open reduction with percutaneous pinning (ORPP).  
This study will look at only Gartland type III SCHFs because they necessitate surgical 
intervention, most commonly CRPP.10, 12 
 

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This study aims to determine the efficacy of nonopioid versus opioid analgesic regimens 
following surgical fixation of Gartland Type III SCHFs to assist in the development of a 
standard outpatient pain management regimen in the treatment of these injuries. 
4.0 
Study Endpoints 
The primary outcome will be subject reported pain level, which will be measured using 
the Wong-Baker Faces Pain Scale.14  The subject reported pain level will be measured at 
the time of discharge (i.e., baseline measure) and at the relative same time each day on 
postoperative days 1-5 (i.e., five follow-up measures).  Thus, subject s may have up to a 
total of six pain level measurements.  
 
Secondary outcomes include: 
1) Parent satisfaction with (subject) child’s pain control measured using a Likert Scale at 
the time of discharge and at the relative same time each day on postoperative days 1-5 
2) Daily use of opioid or nonopioid medicine on postoperative days 1-5 
3) Number of days of medication use 
4) Side effects experienced 
5) Use of medication(s) other than those indicated by their physician to control pain 
6) Number of calls to a healthcare provider for breakthrough pain rescue 
7) Number of visits to a healthcare provider for breakthrough pain rescue 
8) Overall control of patient’s pain in postoperative days 1-5 
9) Overall parent satisfaction with patient’s pain control in postoperative days 1-5 
 
Secondary outcomes 3-9 will be measured using a standard questionnaire, which will 
take approximately five minutes to complete by a parent at the first follow-up visit.    
5.0 
Study Intervention/Investigational Agent 
Acetaminophen is an analgesic and antipyretic approved by the United States Food and 
Drug Administration (FDA) for the treatment of postoperative pain in children.  It is 
approved for over-the-counter use in the form of tablets, chewable tablets, gel tabs, 
capsules and liquid.   
 
Hydrocodone is an opioid analgesic approved by the United States FDA for the treatment 
of postoperative pain in children.  It is approved for prescription use in the form of 
tablets, capsules and liquid.  Hydrocodone is often prescribed with acetaminophen as a 
combination medication (Lortab).   
 
Patients will be randomized into one of two study groups using the REDCap 
Randomization Module.  The Opioid (O) Group will receive a five day prescription for 
oral hydrocodone/acetaminophen at a dose of 0.15mg/kg to be taken every six hours as 
needed in addition to oral ibuprofen at a dose of 10mg/kg to be taken every six hours as 
needed.  The Nonopioid (NO) Group will receive oral acetaminophen at a dose of 
15mg/kg to be taken with oral ibuprofen 10mg/kg every six hours.  At parental discretion, 
patients in both groups will self-transition to taking only oral ibuprofen at a dose of 
10mg/kg every six hours as needed. 
 

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Subjects will go home with their assigned medication available for them from the CMH 
Outpatient pharmacy. At discharge, both groups will follow the standard of care from the 
inpatient unit to obtain their pain medication for home use.  If acetaminophen and/or 
ibuprofen are readily available at home, families may decline purchasing from the CMH 
outpatient pharmacy.   
6.0 
Procedures Involved 
Study Design: 
This is a prospective, two-arm, parallel-group, non-inferiority, randomized study 
including subject 48-119 months of age presenting to Children’s Mercy Hospital for 
surgical correction of Gartland type III SCHFs.  Only subject meeting the 
inclusion/exclusion criteria will be eligible for this study.  All eligible subject will be 
randomized to receive a postoperative outpatient pain management regimen that includes 
opioid analgesics (O group) or a postoperative outpatient pain management regimen that 
does not include opioid analgesics (NO group).  
 
 
Study Overview/Methods: 
All eligible patients meeting the inclusion criteria will be admitted under inpatient status 
until the time of surgery.  Subject will undergo operative treatment of their displaced 
supracondylar humerus fracture within 18 hours of injury.  Subjects will receive standard 
perioperative anesthesia.  Surgeons involved in the study will operate and treat each 
fracture with the reduction and fixation technique they deem appropriate for the 
individual subject.  Subjects will receive ketorolac 0.5mg/kg IV single-dose up to 30mg 
in the operating room at the completion of the procedure.  Subjects will be immobilized 
in either a splint or bivalve fiberglass cast.  Subjects will be treated in the post-anesthesia 
care unit (PACU) with standard pain management.  Subjects will be treated in the 
observation setting with standard pain management and go home within 24 hours of 
surgery.  Patients not admitted pre-op, not admitted post-op or staying longer than 24 
hours after surgery will be excluded from the study.  
 
Parental consent for patient participation in this study will be obtained by an investigator 
prior to discharge from the hospital.  Subjects will then be randomized to receive a 
postoperative pain management regimen that includes opioid analgesics or a 
postoperative pain management regimen that does not include opioid analgesics. The 
randomization will be performed by an investigator using a random-number generator 
(REDCap Randomization Module).  Subjects assigned to the O group will go home with 
a filled opioid prescription.  Subjects assigned to the O or NO group without 
acetaminophen and/or ibuprofen are readily available at home, will go home with the 
needed medications.  If a subject assigned to the NO group calls and needs to be switched 
to the O group, that will be discussed with the attending surgeon and, if approved, that 
subject’s status will be changed.  
 
Measured Outcomes: 
Subject’s pain will be assessed in the outpatient period using the Wong-Baker Faces Pain 
Rating Scale.  Subject’s pain scores will be recorded at the time of discharge and at 

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approximately the same time each day for postoperative days 1-5.  Subjects will rate their 
pain at the time of the survey. 
 
Parent satisfaction with their child’s pain control will be assessed using a Likert Scale, 0-
10 scale.  Parent satisfaction scores will be recorded at the time of discharge and at the 
same time each day for postoperative days 1-5.  Parents will rate their satisfaction with 
their child’s pain control at the time of the survey.  
 
The use of opioid or nonopioid medications will be reported at the same time each day 
for postoperative days 1-5.  Parents will report if their child took their assigned 
medications in the past 24 hours at the time of the survey.  
 
The patient pain score and parent satisfaction score will be recorded using a three-
question survey administered by the CMH-REDCap database.  A unique link will be sent 
to a parental email address for each survey through CMH-REDCap automated 
invitations.  A reminder email will be sent six hours after the first email. Surveys will 
expire 36 hours after the first invitation to each link was sent.  We will be using Twilio 
REDCap texting as means of survey distribution in addition to email.  
 
All subjects will be scheduled to return to the CMH orthopedic clinic for three follow-up 
visits at approximately two, four and eight weeks post-op.  These clinic visits are part of 
the standard practice at CMH.  At 10 days post-op, we will record the days of medication 
use and the number of days to return to normal activity.  We will Side effects 
experienced, used of medication(s) other than those indicated by their physician for pain 
control, number of call-ins for breakthrough pain rescue, number of unplanned visits to a 
healthcare provider for breakthrough pain rescue, overall control of patient pain and 
overall parent satisfaction with their patient pain control in postoperative days 1-5 will be 
assessed using a questionnaire completed by a parent.  Standard of care X-ray images and 
physical exam will be used throughout follow-up visits to assess for complications.   
 
7.0 
Data and Specimen Banking - N/A 
8.0 
Genetic Analysis Information - N/A 
9.0 
Sharing of Results with Subjects- NA 
10.0 Study Timelines 
Each subject will participate in the study for approximately two months from the date of 
injury.  This time period includes the initial presentation for injury evaluation, surgical 
treatment and all follow-up visits. Data will be collected from each encounter.  
 
Given the volume of Gartland type III SCHFs that present yearly to CM-Adele Hall 
Campus, it is expected all study subjects will be enrolled within 18 months from the start 
date of this study.  It will take approximately two years from the start date for 
investigators to complete this study. 
11.0 Inclusion and Exclusion Criteria 

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Inclusion Criteria:  
• Patients presenting to Children’s Mercy Hospital  
• Patients 48-119 months of age  
• Closed and completely displaced Gartland type III SCHFs (ICD-10 codes: 
S42.411A, S42.412A and S42.413A) 
 
Exclusion Criteria:   
• Patients younger than 48 months of age or older than 120 months of age 
• Nondisplaced SCHFs (ICD-10): S42.414-, S42.415- and S42.416-) 
• Open and completely displaced Gartland type III SCHFs (ICD-10: S42.411B, 
S42.412B and S42.413B) 
• Injury requiring open reduction and/or vascular injury requiring treatment 
• Patients presenting with additional injuries 
• Patients with known allergy to medications used in this study 
• Patients receiving regular treatment with opioids or NSAIDs 
• Patients with underlying medical issues affecting cognitive status 
• Patients with hepatic, gastrointestinal, renal or hematologic disease/disorders 
• Children that are wards of the state, prisoners or of CM employees 
• Non-English speaking families 
• Patients not admitted before and after surgery  
• Fractures not surgically treated within 18 hours of injury 
• Use of local anesthetic at surgical site 
12.0 Vulnerable Populations 
This study involves no more than minimal risk to the children presented to the 
intervention.  The interventional drugs used in this study will be prescribed as approved 
by the United States FDA for the treatment of postoperative pain in children.  The 
imaging, procedures, medications, clinic visits and any other medical care outlined in this 
protocol are all part of the usual care provided to the patient.  
 
Permission will be attained from a biological parent.  After a parent has given permission 
for their child to participate in the study, assent will be attained from children 7 years of 
age and older per CMH policy.    
 
 
13.0 Local Number of Subjects 
According to the CM orthopedic trauma registry, at CMH, approximately 320 children 
with SCHFs present annually. Of those 320 SCHFs, approximately 150 (47%) are 
Gartland type III fractures. 
 
A minimum of 160 subjects will be accrued locally, 80 for each study arm.  It is 
anticipated 20% of subjects presenting annually will be ineligible for this study, miss 
enrollment or decline enrollment.  It is further anticipated 20% of enrolled subjects will 
be lost to follow-up.  Therefore, it is expected that up to 300 patients may need to be 

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screened in order to acquire the necessary number of participants who meet the inclusion 
and exclusion criteria.  It will take an estimated 20 months to enroll 160 total subjects. 
 
If more than 300 subjects need to be screened or more than 160 eligible subjects are 
identified in less than 20 months, an amendment will be submitted to the IRB to increase 
the number of subjects prior to the collection of any data beyond the originally approved 
number.  Evaluating a larger group of patients may allow for more statistically significant 
conclusions to be drawn regarding the efficacy of nonopioid analgesic regimens 
compared to opioid analgesic regimens in the treatment of postoperative pain in children 
following surgical correction of Gartland type III SCHFs.  
14.0 Screening and Recruitment Methods 
All staff orthopedic surgeons at Children’s Mercy Hospital and rotating residents 
will be informed of the study.  Any child presenting to or referred to CMH for 
surgical treatment of a Gartland type III SCHF will be screened for eligibility by 
the orthopedic resident and/or surgeon involved in their care.  Upon identifying a 
child meeting all inclusion and exclusion criteria, the resident and/or surgeon will 
notify a study team member of an eligible study patient and the date/time of the 
patient’s surgery.  One of the study team members will discuss the study with the 
patient and family for the purpose of obtaining consent prior to discharge.   
 
Minimum PHI will be recorded prior to obtaining informed consent.  Minimum 
PHI on non-participants will be recorded until the completion of enrollment in 
order to avoid duplicate enrollment and to track where patients become ineligible 
for the study or why they chose not to participate in the study.  We are requesting 
partial Waiver of HIPAA authorization of recruitment purposes only.  
 
15.0 Withdrawal of Subjects 
Subjects will be withdrawn from the research without their consent if they have an 
allergic reaction to any one of the study medications, suffer any major adverse effect 
from a medication or procedure or develop a complicated case requiring unusual or 
extended treatment.  
 
The study will undergo orderly termination if it is associated with unexpected serious 
harm to the subjects.    
 
Data collected from subjects up until the time of voluntarily or involuntarily withdrawal 
from the research will be retained unless deletion is requested by a parent.  
16.0 Risks to Subjects 
This study involves no more than minimal risk to the children presented to the 
intervention.  Risks may include adverse effects related to the FDA approved study 
drugs.   
It is possible to have an allergic reaction to any of the study drugs.  Allergic reactions 
usually happen right away after taking the medicine by mouth and symptoms include 
hives, swelling of the throat, and trouble breathing.  These reactions are rare.  These risks 

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are no more than minimal as the interventional drugs used in this study will be prescribed 
as approved by the United States FDA for the treatment of postoperative pain in children.  
The medications, imaging, procedures, clinic visits and any other medical care outlined in 
this protocol are all part of the usual care provided to the patient. 
 
There is a slight risk of loss of confidentiality.  Subjects’ confidentiality will be protected 
to the greatest extent possible.  Each subject’s confidential medical information will be 
maintained in the medical record as well as in a special study record that has the data 
collection sheet and a copy of this permission/assent form.  We will keep personal 
identifiers separate from the study data.  The study record will be locked and maintained 
in the research coordinator’s office.  
 
There also is a risk to confidentiality when using the internet.  By providing an email 
address, the study team may communicate with the subject regarding survey links, survey 
reminders, appointment reminders and any other non-clinical, study related 
communication. We will be using Twilio REDCap texting as means of survey 
distribution in addition to email 
• 
Corresponding through email or text is not a secure method of sending 
information and others may be able to access the information sent. 
• 
The information may not be secure if storing or viewing the permission/assent 
document on a personal electronic device (PED), especially if that PED is shared 
with other users or is lost, hacked, or subject to a search warrant or subpoena. 
• 
Information that is sent through e-mail or text may be kept on the Hospital's or 
subjects’ service provider's (Google, Yahoo, MSN, etc) network servers. Unlike 
paper copies, e-copies delivered directly to the subjects’ PED may not be able to be 
permanently removed. 
 
This is a prospective randomized controlled trail using secured data from patient 
CM-Cerner accounts.  There is a minimal risk of a breach in confidentiality of the 
PHI of subjects involved with this study.  All data will be secured in a password 
protected CM-REDCap database available only to approved study members.  If 
there is a breach of confidentiality, the study coordinator will submit a reportable 
event to the Pediatric Institutional Review Board (IRB) at The Children’s Mercy 
Hospital and Clinics and work with the study team to resolve the situation.  
17.0 Potential Benefits to Subjects 
This study may not directly benefit individual subjects taking part in the research.  
 
18.0 Investigator Assessment of Risk/Benefits Ratio: (IRB makes the 
final determination)  
 
Select as applicable: 
Pediatric Risk Category: 
X 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
 
19.0 Data Management and Confidentiality 

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This study was powered to detect a between-group difference in the primary outcome of 
patient reported pain level.  A difference in pain intensity of one face on the Faces Pain 
Scale (0-5) has been shown to be a minimal clinically important difference.5 Referencing 
the numbers in the Poonai et al article, a sample size estimate of 80 and 80 per group 
(160 total) achieves 80% power to detect non-inferiority using a two-sided, Mann-
Whitney test assuming that the actual distribution is uniform; margin of non-inferiority is 
1.0.  The true difference between the means is assumed to be 0.0. The significance level 
(alpha) of the test is 0.05.  The data are drawn from populations with standard deviations 
of 2.0 and 2.0. 
 
This is a randomized study of 160 subjects 48-119 months of age who present to CMH 
for surgical treatment of Gartland type III SCHFs.  Subjects will be randomly allocated to 
O group or NO group and followed for up to 12 weeks after surgery.  Outcome measures 
include daily patient pain level, daily parent satisfaction, daily use of medications, total 
number of days of medication use, side effects experienced, list of all medications used, 
number of calls/visits to healthcare provider for breakthrough pain rescue, overall pain 
control and over parent satisfaction with pain control.  Additional data collected at study 
completion includes patient demographics, occurrence of complications, and functional 
and assessment of surgical treatment.  
 
Patients will be randomly allocated to the O group (n=80) and NO group (n=80). The 
primary outcome will evaluate differences in patient reported pain levels between these 
two groups from baseline up to and including postoperative day 5. Secondary outcomes 
will evaluate differences between these two groups from baseline up to and including 
postoperative day 5 and for patients who return to the CMH orthopedic clinic for three 
follow-up visits at approximately two, four and eight weeks post-op. 
 
Mann-Whitney Wilcoxon (two-sided) tests will be used to compare patient pain levels 
between patients with opioid regimen compared to patients with nonopioid regimen for 
each of the five postoperative days. Regression techniques will also be used to compare 
the slopes between these patients over the five postoperative days. Data will be examined 
to determine if demographics and characteristics are related to patients changing 
treatment regimens and/or leaving the study. Descriptive statistics will be conducted to 
describe the characteristics of the sample. P-values (two-sided) <0.05 regarded as 
statistically significant. Data analysis will be conducted using Stata 14.2 software 
(StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp 
LP). 
 
PHI will be collected and stored in the CMH-REDCap database including patient first 
name, last name, date of birth, MRN, parent first name, parent last name, parent email 
address, and dates and times of service. 
 
Subject information recorded at presentation will include age, gender, drug allergies, 
current medications, cognitive impairment, comorbidities, laterality of injury, mechanism 
of injury, extension or flexion injury, direction of displacement, open injury, additional 
injury, vascular injury and neuropraxia. Surgical information to be collected will include 

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surgeon, reduction technique, number of pins placed, location of pins placed, use of local 
anesthetic, time between presentation and injury, duration of surgery, and number of 
doses of opioid/nonopioid medication received postoperatively prior to discharge. Further 
information to be collected will include the time between discharge and each follow-up 
visit. 
 
Data will be collected and stored in the password protected CM-REDCap database.  No 
data will be available or shared with any other entity or individual than the listed study 
personnel.  Only the data points of interest will be available for analysis. As soon as all 
data points are entered into the research database, a master linking list will be maintained 
that links each subject’s medical record number with their study number.  Subjects not 
meeting the more specific inclusion/exclusion criteria will be removed from the list and 
no data will be recorded.  Security measures include the storage of all data on a password 
protected computer in a restricted assess departmental folder limited to only listed study 
personnel.   
 
Per the guidelines, data will be store for the longer of the following:  (1) Five years from 
the date of publication, or if not published (2) Five years from completion of all reporting 
requirements, or (3) At least three years after the final report is completed and accepted 
by the IRB. 
 
A Certificate of Confidentiality has not been issued for this study.   
 
Study data will be evaluated by the PI after every 30 subjects are enrolled and throughout 
the duration of the study for Quality Control. 
20.0 Provisions to Monitor the Data to Ensure the Safety of Subjects - 
N/A 
21.0 Provisions to Protect the Privacy Interests of Subjects 
PHI to be accessed and/or recorded for this research study will include: last name, 
first name, date of birth, medical record number, and date(s) of service. PHI will 
be stored in the password protected CMH-REDCap database.  No subject’s PHI 
will be available or shared with any other entity or individual than the study 
personnel.  Only the data points of interest will be available for analysis.  As soon 
as all data points are entered into the research database, a master linking list will 
be maintained that links each subject’s medical record number with their study 
number.  Subjects not meeting the more specific inclusion/exclusion criteria will 
be removed from the list and no data recorded.  
HIPAA Authorization from subjects will be wrapped in with the 
permission/assent/consent form.  
22.0 Compensation for Research-Related Injury - N/A 
23.0 Economic Burden to Subjects 

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All procedures, treatments, medications and clinic visits involved in this study are part of 
usual medical care.  Subjects will not have to pay anything extra to participate in the 
study.  There are no additional costs to the subject’s guardian or the subject’s insurance.  
 
This study does not pay for any of the costs of the subject’s care. The subject’s insurer 
will be responsible for all costs related to their treatment, including but not limited to 
surgery, medications, follow-up visits, imaging and any other related expense.  The 
subject’s guardian(s) will be responsible for any costs the subject’s insurer does not 
cover.  If the guardian(s) has any questions about these costs or what out-of-pocket 
expenses they may be responsible for, they should contact the subject’s insurer or 
hospital billing office.  
24.0 Permission/Assent/Consent Process 
The process of informed permission, consent and assent will take place at patient bedside 
prior to discharge from the hospital. 
 
Permission will be attained from a parent.  The permission of one parent is sufficient 
even if the other parent is alive, known, competent, reasonably available and shares legal 
responsibility for the care and custody of the child.  Permission will not be obtained from 
individuals other than parents.  
 
After a parent has given permission for their child to participate in the study, assent will 
be attained from some children involved in this study according to the regulations 
outlined in the CMH Research Policy and Procedures.  Assent will be attained from 
children 7 years of age and older.  Assent for these children under 7 years of age is 
waived under 45 CFR §46.408(c)/45 CFR §50.55(c) for this study.  The research involves 
no more than minimal risk to the subjects, the waiver will not adversely affect the rights 
and welfare of the subjects, the research could not practicably be carried out without the 
waiver or alteration and whenever appropriate the subjects will be provided with 
additional pertinent information after participation.   
25.0 Process to Document Permission/Assent/Consent 
This study will document permission/assent/consent as outlined in “CM Research Policy 
10.04 Obtaining Permission/Assent/Consent.” 
26.0 Setting 
Eligible subjects will be identified and recruited at Children’s Mercy Adele Hall Campus.  
Subjects may present directly to CMH or be referred to CMH from other hospitals for 
evaluation and surgical intervention.  All surgical interventions will be completed at 
CMH.  Subjects will be seen for follow-up visits in the Orthopedic Surgery Clinic most 
convenient for them at either CMH, CM-Kansas, CM-Northland or CM-East. 
 
This protocol, and any subsequent modifications, will be reviewed and approved by the 
Pediatric IRB at The Children’s Mercy Hospital & Clinics.   
 

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The study may be modified or discontinued at any time by the IRB, the Office for Human 
Research Protections, the United States Food and Drug Administration or other 
government agencies as part of their duties to ensure that research subjects are protected. 
We will be using an IRB approved flyer-notification for CMH staff that will be working 
with this population so they are aware of the study and to notify the research coordinator 
of possible patients that should be screened.   
 
27.0 Resources Available 
Approximately 320 children with SCFs preset to CMH campus annually.  Of those 320, 
approximately 150 are Gartland type III SCHFs.  We anticipate 20%of those 150 will be 
ineligible for the study, miss enrollment or decline enrollment.  The study team will be 
trained to obtain the permission/consent/assent and document the process in Cerner.  All 
study members are current in the review of this study and its procedures.   Caleb Grote, 
MD, PhD and Lisa Berglund, MD will work with the assigned investigators, consultants, 
and student/resident weekly to review the study progress.  We plan to complete this 
project in 20-24 months from the start date. 
28.0 Multi-Site Research – Study team members from local academic institutions 
such as UMKC & KUMC will assist on this project.  A reliance will be established with I 
the home institution.  The relationship with these institutions is for study team member 
education and experience purposes only.  No subjects or research activities will occur 
onsite at the external academic institutions.   
 
28.0 International Research - N/A 
29.0 References 
1. Fuad Alkhoury, Colin Knight, Steven Stylianos, et al. “Prospective Comparison 
of Nonnarcotic versus Narcotic Outpatient Oral Analgesic Use after Laparoscopic 
Appendectomy and Early Discharge.” Minimally Invasive Surgery, vol. 2014, 
Article ID 509632, 3 pages, 2014. 
 
2. Tubbs, R., Law, C., Davis, D., et al. “Scheduled oral analgesics and the need for 
opiates in children following partial dorsal rhizotomy.” J Neurosurg (6 Suppl 
Pediatrics). 2007;106:439-440. 
 
3. Tobias, J.D. “Acute Pain Management in Infants and Children – Part 1: Pain 
Pathways, Pain Assessment, and Outpatient Pain Management.” Pediatric Annals. 
2014;43(7):e163-e168.  
 
4. Tobias, J.D. “Acute Pain Management in Infants and Children – Part 2: 
Intravenous Opioids, Intravenous Nonsteroidal Anti-Inflammatory Drugs, and 
Managing Adverse Effects.” Pediatric Annals. 2014;43(7):e169-e175.  
 

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5. Poonai, N., Datoo, N., Ali, S., et al. “Oral morphine versus ibuprofen 
administered at home for postoperative orthopedic pain in children: a randomized 
controlled trial.” Canadian Medical Association Journal. 2017;189:e1252-e1258. 
 
6. Dorkham, M.C., Chalkiadis, G.A., von Urgern Sternberg, B.S., et al. “Effective 
postoperative pain management in children after ambulatory surgery, with a focus 
on tonsillectomy: barriers and possible solutions.” Pediatric Anesthesia. 
2014;24:239-248. 
 
7. Austin, A.E., Shanahan, M.E. and Zvara, B.J. “Association of childhood abuse 
and prescription opioid use in early adulthood”. Addictive Behaviors. 
2018;76:265-269. 
 
8. Dart, R.C., Surratt, H.L., Cicero, T.J., et al. “Trends in Opioid Analgesic Abuse 
and Mortality in the United States”. The New England Journal of Medicine. 
2015;372:272-248. 
 
9. Cartabuke, R.S., Tobias, J.D., Taghon, T., et al. “current Practices Regarding 
Codeine Administration Among Pediatricians and Pediatric Subspecialists”. 
Clinical Pediatrics. 2014;53(1):26-30. 
 
10. Marquis, C.P., Cheung, G., Dwyer, J.S.M., et al. “Supracondylar fractures of the 
humerus”. Current Orthopaedics. 2008;22:62-69. 
 
11. Chaturnedi, H., Khanna, V., Bhargava, R. et al. “Predictive factors determining 
outcomes in pulseless limb in paediatric supracondylar fractures of humerus”. 
Journal of Clinical Orthopaedics and Trauma. 2018;9(1):92-96. 
 
12. Woon, C., Souder, C. and Skaggs, D. “Supracondylar Fracture - Pediatric”. 
Orthobullets. https://www.orthobullets.com/pediatrics/4007/supracondylar-
fracture--pediatric. (17 July 2018). 
 
13. Flynn, JC, Matthews, JG and Benoit, RL. “Blind pinning of displaced 
supracondylar fractures of the humerus in children. Sixteen years’ experience 
with long-term follow-up.” The Journal of Bone and Joint Surgery. 
1974;56(2):263-272 
 
14. The Wong-Baker FACES Foundation: Faces of Pain Care. c2016. Published 
2018. Wong-Baker FACES Foundation. [Accessed 11 Oct. 2018]. 
http://wongbakerfaces.org.