Clinical trial NCT03464461
Conditions: Acute Pain
Sponsor: University of Missouri-Columbia
Start date: 2018-05-01; Completion date: 2024-05-30
Enrollment: 289 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

Detailed description:
Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.

Arms: arm 1: 0 mg ketorolac - placebo arm 2: 10 mg ketorolac - low dose ketorolac arm 3: 30 mg ketorolac - usual dose ketorolac
Interventions: intervention 1: Ketorolac
Intervention descriptions: intervention 1: IV drug

Protocol documents:
ICF_001.pdf: 
 
 
Consent Form and HIPAA Authorization 
for Participation in a Research Study 
Study Name: Dosing of Ketorolac 
Investigator’s Name: Matthew Robinson, MD 
Project IRB #: 2010856 HS 
NCT number: NCT03464461 
IRB approval date: March 09, 2022 
 
 


 
 
 
Study ID #:  
RA Initials:  
Date:  
 
 
 
 
Consent Form and HIPAA Authorization 
for Participation in a Research Study 
Investigator’s Name: Matthew Robinson, MD 
Project IRB #: 2010856 HS 
 
Study Title: Dosing of Ketorolac 
We invite you to take part in this research study. This consent form tells you why we are doing 
the study, what will happen if you join the study, and other important information about the 
study. 
 
Please take as much time as you need to read this consent form. You can discuss it with your 
family, friends, or doctor. If there is anything you do not understand, please ask us to explain. 
Then you can decide if you want to take part in the study or not. 
 
The Principal Investigator (also called the study doctor) is Matthew Robinson, MD. The people 
working with Dr. Robinson on this study are called the study team. 
 
What Should I Know Before I Decide Whether To take part In This Study? 
• Research studies like this one help us to learn new things and test new ideas about 
treating certain conditions/diseases. 
• Taking part in a research study is voluntary. You decide if you want to take part, and you 
can stop taking part at any time. Your regular medical care at the University of Missouri 
Hospitals and Clinics will not be affected now or in the future if you decide you do not 
want to be in this study. 
• We are doing this study because we want to know more about the effectiveness of the 
non-steroidal anti-inflammatory drug (NSAID) called ketorolac for your pain. 
• We invite you to take part in this study because you are seeking treatment in our 
Emergency Department for acute pain from a headache, a viral infection, your 
abdomen, or mild to moderate musculoskeletal injury. 
• If you take part in this study, you will receive one of 3 study drugs, one of which may be 
a placebo. 


 
 
 
• At the end of the study period, your regular medical care will continue and address any 
further pain or health concerns. 
• About 500 people will take part in this study at the University of Missouri. 
• The total amount of time you could be in this study is about 40 minutes. 
• There is no guarantee that taking part in this research will result in any improvement 
in your condition. 
• As with any research study, there are risks that we know about and there may be some 
we don’t know about. We will explain these risks in this form. 
• We will only include you in this study if you give us your permission first by signing this 
consent form. 
 
Why Are The Researchers Doing This Study? 
In this study, we want to find out if one dose of the commonly used NSAID for pain called 
ketorolac (also called Toradol® or the study drug in this form), works better than another dose 
or better than a placebo. To do this, we will compare two doses of ketorolac and placebo in 
people with acute pain from a headache, a viral infection, their abdomen, or mild to moderate 
musculoskeletal injury to see which one is more effective at treating pain. 
 
Ketorolac is approved by the U.S. Food and Drug Administration (FDA) to treat patients with 
your type of pain, and your doctor may prescribe it to you for your pain even if you chose not to 
be in this study. 
 
What will happen if I take part in this study? 
If you decide to join this study, you will sign this form and then you will be asked to rate your 
pain using a pain scale now and 30 minutes or later after receiving the study drug. 
 
Research Study Groups 
To find out if one dose of ketorolac works better than another or placebo for pain, this study 
has 3 groups. All three groups (including placebo) will receive a study drug that is known to 
have pain-relieving effects. Each group will be given a small amount of saline IV fluids (sodium 
chloride 0.9% 50 mL) as an infusion that will take 2 – 5 minutes through the IV. One group will 
have ketorolac 30 mg in the saline fluids, another group will have ketorolac 10 mg in the saline 
fluids and the last group will only receive the saline fluids. The group that only receives the 
saline fluids is called the placebo group. 


 
 
 
We will re-check your pain on the pain scale at least 30 minutes after. We will also ask you 
about any negative affects you experienced. After the second pain survey, your involvement in 
the study will be completed, and you will be treated by your Emergency Department team for 
any continuing pain or health concerns, if needed. 
 
Because we don’t know which of the drugs is best, we will “randomize” you into one of the 3 
study groups. “Randomize” means putting you into a group by chance. It is like flipping a coin or 
pulling a number from a hat. You will have a one in three chance of being placed in any group. A 
computer program chooses which group you go in. You and your care provider cannot choose 
which group you go into. 
 
This study is “blinded”, which means that you or anyone on the study team will not know which 
drug you received until the end of the study. This way, no one’s expectations of what will 
happen in the study will affect the results. In an emergency, the study doctor can find out which 
drug you are getting. 
 
Study Tests and Procedures 
• If you take part in this study, you will have the following procedures: 
• If you are a woman and could be pregnant, you will need a pregnancy test. You may 
have received a pregnancy test as part of your Emergency Department evaluation 
already, but if you haven’t, a urine pregnancy test will be provided. We will tell you and 
your provider the result of this test. 
• You will rate your pain before you get a test drug using a pain scale 
• You will be given one of the 3 test drugs 
• 30 minutes or after you will be asked to rate your pain on the pain scale again 
 
We will keep the information we collect from you for this study to use in future research or to 
share with other investigators to use in future studies without asking for your consent again. 
Information that could identify you will be removed from your research data so no one will 
know that it belongs to you. 
 
How Long Will I Be in the Study? 
You will be in this study for about 40 minutes total. It will take 5-10 minutes to evaluate your 
pain and prepare you for the study. The study procedure will last 30 minutes. If you are unable 
to complete the re-evaluation survey at 30 minutes, we will have you complete it as soon as 
possible after that time. 


 
 
 
Can I Stop Being In The Study? 
 
You can stop being in the study at any time without giving a reason. If you stop being in the 
study, your regular medical care will not change. Leaving the study will not affect your future 
medical care at the University of Missouri. 
 
There is no penalty to you if you do not join the study or if you leave it early. You will not lose 
any benefits you are entitled to if you leave the study. 
 
If you decide to stop participating in the study, you should discuss your decision with the study 
doctor. The study doctor may decide to take you off this study at any time, even if you want to 
stay in the study. The study doctor will tell you the reason why you need to stop being in the 
study. 
 
If necessary, the study doctor will arrange for you to continue your medical care with your 
regular doctor. 
 
What Health Risks or Problems Can I Expect From The Study? 
There are risks to taking part in any research study. There is a risk that you may get a drug dose 
that does not help your pain. There may also be problems (also called side effects) we do not 
know about yet. If we learn about new important risks and side effects, we will tell you. We will 
tell you about any new information we learn that may affect your decision to continue taking 
part in the study. 
 
Ketorolac can affect people in different ways. Not everyone gets the same side effects. Side 
effects may be mild or very serious. Many go away soon after the drugs are stopped. Some side 
effects can last a long time or never go away. You may receive other drugs to make side effects 
less severe and uncomfortable. Complications of some of the side effects listed below may lead 
to life-threatening events such as allergic reaction, headache, heartburn, upset stomach, 
nausea, vomiting, diarrhea, stomach pain, bloating, gas, constipation, dizziness, drowsiness, 
sweating, and ringing in the ears. 
 
We will closely watch everyone in the study for side effects. You need to tell the study doctor 
immediately if you have any problems, side effects, or changes in your health. Dr. Robinson’s 
telephone number is 573-884-4400. For more information about risks and side effects, ask the 
investigator or talk to your health care provider today. 
 


 
 
• Randomization risks: You will be put into a group by chance. The drug dose you receive 
may turn out to be less effective or have more side effects than that in the other groups. 
It may also be less effective and have more side effects than other drugs available for 
pain. While you are in this study, we will not know which drug you are getting. If your 
condition gets worse during the study and we need to know which drug you are getting, 
there will be a way for us to find out. 
 
• Placebo risks: This study includes a placebo group. If you are placed in the placebo 
group, you will not receive pain medication for your condition for 30 minutes or until 
the re-evaluation survey is completed. However, other studies have shown that other 
people receiving saline as a placebo have felt pain relief when it was administered. 
 
• Reproductive Risks: The effects of ketorolac on a developing fetus are unknown but 
could cause harm. For this reason, it may be necessary to test for potential pregnancy if 
applicable. If you have any questions about the reproductive issues or about preventing 
pregnancy, please discuss them with the investigator or your doctor. You must tell the 
study doctor right away if you think you are pregnant. 
 
Are There Benefits to Taking Part in the Study? 
If you agree to take part in this study, there may or may not be direct medical benefit to you. 
You may expect to benefit from taking part in this research to the extent that you are 
contributing to medical knowledge. We hope the information learned from this study will 
benefit other patients with pain in the future. 
 
There is no guarantee that taking part in this research will result in any improvement in your 
condition. 
 
What Other Choices Do I Have? 
 
You do not have to take part in this study. You are free to say yes or no. If you do not want to 
join this study, your doctor will discuss other choices with you. You may get drugs for pain 
management including ketorolac even if you do not take part in the study. 
 
What About Privacy And Confidentiality? 
The study team needs to access some of your health/personal information. This information 
comes from questions we ask you, forms you fill out, and your medical record. One risk of 
taking part in a research study is that more people will handle your personal health 
information. We are committed to respecting your privacy and to keeping your personal 


 
 
information confidential. The study team will make every effort to protect your information and 
keep it confidential to the extent allowed by law. However, it is possible that an unauthorized 
person will see it. 
 
State and federal privacy laws (HIPAA) protect the use and release of your health information. If 
you decide to take part in this study, you also give us your permission to use your private health 
information, including the health information in your medical records and information that can 
identify you. 
 
You have the right to refuse to give us your permission for us to use your health information. 
However, doing so would mean that you could not take part in this study. 
 
The following identifiers will be obtained from your health records: 
Name 
Medical Record Number 
Dates related to you 
 
The following is the type of protected health information that will be used in the study: 
Radiology Images 
Discharge Summaries 
Radiology Reports 
Consultations 
Progress Notes 
History and Physical Exams 
Medications 
Emergency Medicine Reports 
Operative Reports 
Pathology Reports 
Demographics (age, race, etc.) 
Laboratory Reports 
Questionnaires, Surveys, Diaries 
 
We may share any of this information with the following: 
• Authorized members and staff of the University of Missouri Institutional Review Board 
(IRB). 
• Study monitors and auditors who make sure that the study is being done properly. 
• Government agencies and public health authorities, such as the Food and Drug 
Administration (FDA), the Department of Health and Human Services (DHHS), and the 
Office for Human Research Protections (OHRP) 
 
Any research information shared with outside entities will not contain your name, address, 
telephone or social security number, or any other personal identifier unless it is necessary for 
review or required by law. 
The people who get your health information may not be required by Federal privacy laws (such 
as the HIPAA Privacy Rule) to protect it. Some of those people may be able to share your 


 
 
information with others without your separate permission. 
 
Your permission for us to use and/or release your information will last until the end of the study 
unless you cancel your permission. You can cancel your permission at any time by writing to: 
 
Investigator’s Name: Matthew Robinson 
Institution: University of Missouri 
Department: Emergency Medicine-Research 
Address: One Hospital Drive – DC029.1 
Columbia, MO 65212 
 
The information we have already collected may still be used for this research study, but we will 
not collect any more information after we receive your letter. 
 
You have the right to access your protected health information that is obtained or created 
during this research project until the end of study ends. 
 
If you have not already received a copy of the University of Missouri Healthcare Privacy Notice, 
you may request one. If you have any questions or concerns about your privacy rights, you may 
contact the Privacy Officer at 573-882-9054. 
 
Information that does not become part of your medical record will be stored in the 
investigator’s electronic/computer or paper files. Computer files are protected with a password 
and the computer is in a locked office that only study team members can open. Paper files are 
kept in a locked drawer in a locked office that only study team members can open. 
 
Your records will be given a code number and will not contain your name or other information 
that could identify you. The code number that connects your name to your information will be 
kept in a separate, secure location. Information that may identify you may not be given to 
anyone who is not working on this study without your written consent, or if required by law. 
 
The people who may use and/or release your research information include: 
• Those working on the study team at the University of Missouri 
• The members of the University of Missouri Institutional Review Board (IRB) 
• Those who check on research activities to make sure it is being done correctly and safely 
• The FDA 
• Other government or inspection agencies 
 
We may present the results of this study in public talks or written articles, but we will not use 


 
 
information that can identify you. 
 
Can I See My Research Records? 
If you join this study, you will be given one of 3 study drugs, without knowing exactly which 
one. This is called a “blinded” study. This is a way of doing research when we want to compare 
drugs, and we don’t want people’s feelings about the drugs to affect the results. 
 
If you ask to see your health records during this blinded study, the study team cannot tell you 
which drug you got. This is because the study team is also blinded to which drug you are 
getting. You would have to wait until all participants have completed the study. If we need the 
blinded information to treat you for an emergency, the study doctor will be able to find out. 
 
Are There Any Costs To Being In The Study? 
Some tests and procedures are only done because of the research. The study will pay for any 
medications or procedures that are only done because you are in this study. There is no cost to 
you for the study drug itself. However, you will be paying for the normal cost of your 
Emergency Department visit and your routine medical care. Any procedure related solely to 
research that would not otherwise be necessary will be explained. Some of these procedures 
may result in added costs and some of these costs may not be covered by your insurance. Your 
doctor will discuss these with you. 
In addition, the use of other medications to help control side effects could result in added costs 
that may or may not be covered by your medical insurance. 
 
Will I be Paid for Taking Part in this Study? 
There is no payment to you for taking part in this study. 
 
What Happens If I Am Injured During The Study? 
It is not the policy of the University of Missouri to compensate human subjects in the event the 
research results in injury. The University of Missouri, in fulfilling its public responsibility, has 
provided medical, professional and general liability insurance coverage for any injury in the event 
such injury is caused by the negligence of the University of Missouri, its faculty and staff. 
The University of Missouri also will provide, within the limitations of the laws of the State of 
Missouri, facilities and medical attention to subjects who suffer injuries while participating in the 
research projects of the University of Missouri. 
 
In the event you have suffered injury as the result of participation in this research program, you 
are to contact the Risk Management Officer, telephone number (573) 882-1181, at the Health 


 
 
Sciences Center, who can review the matter and provide further information. 
This statement is not to be construed as an admission of liability. 
 
What Are My Rights as a Study Participant? 
Taking part in this study is voluntary. You do not have to take part. Your present or future 
medical care will not be affected if you decide not to take part. 
 
If you do decide to take part, you can change your mind and drop out of the study at any time. 
This will not affect your current or future care at the University of Missouri Hospitals and 
Clinics. There is no penalty for leaving the study and you will not lose any benefits that you are 
entitled to receive. 
 
If the study investigator decides to take you off the study, he/she will explain the reasons and 
help arrange for your continued care by your own doctor, if needed. 
 
We will tell you about any new information discovered during this study that might affect your 
health, welfare, or change your mind about taking part. 
Where Can I Get More Information About This Study? 
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. 
law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
 
Who Can Answer My Questions About The Study? 
If you have more questions about this study at any time, you can call Dr. Robinson at 573-884- 
4400. You may also contact the University of Missouri Institutional Review Board (IRB) if you: 
• Have any questions about your rights as a study participant; 
• Want to report any problems or complaints; or 
• Feel under any pressure to take part or stay in this study. 
The IRB is a group of people who review research studies to make sure the rights of participants 
are protected. Their phone number is 573- 882-3181. 
 
If you want to talk privately about your rights or any issues related to your participation in this 
study, you can contact University of Missouri Research Participant Advocacy by calling 888-280- 
5002 (a free call), or emailing MUResearchRPA@missouri.edu. 
 
We will give you a copy of this consent form. Please keep it where you can find it easily. It will 
help you to remember what we discussed today. 


 
 
 
Signature of Study Participant for Consent to Participate in Research 
By signing my name below, I confirm the following: 
• I have read/had read to me this entire consent form. 
• All of my questions were answered to my satisfaction. 
• The study’s purpose, procedures, risks and possible benefits were explained to me. 
• I voluntarily agree to take part in this research study. I have been told that I can stop at 
any time. 
 
Subject’s Signature/ LAR Signature 
Date 
 
 
 
 
Reason for LAR Signature 
Tech Initials/Date 


 
 
 
 
Signature of Witness (if applicable)* 
Date 
 
 
 
 
Reason for Witness Signature 
Tech Initials/Date 
 
*A witness is required when a participant is competent to provide consent but is blind, or cannot 
read or write. 
Signature of Person Authorized to Obtain Consent* 
I have explained the purpose of the research, the study procedures (identifying those that are 
investigational), the possible risks and discomforts and potential benefits of the study, and have 
answered questions regarding the study to the best of my ability. 
 
Signature of Person Authorized to Obtain Consent 
Date 
 
 
 
Printed Name of Person Authorized to Obtain Consent Tech Initials/Date 
 

Prot_SAP_002.pdf: 
Study Title: Dosing of ketorolac 
NCT: NCT03464461 
Date: 5/12/2021 
 
 
 


Dosing of ketorolac 
 
Kara Goddard Pharm.D., Julie Stilley PhD., Matthew Robinson MD 
 
 
 
 
 
 
05/12/2021 v6 
 
1. 
Objective and Specific Aims 
The non-steroidal anti-inflammatory drugs (NSAID’s) are very commonly used to treat pain in 
Emergency Departments.  In January of 2018 more than 1100 doses of the injectable NSAID 
ketorolac were given in the University of Missouri Emergency Department.  The correct dosing 
of ketorolac is unclear.   
Our study is designed to clarify the optimal dose of ketorolac. 
2.  
Background and Significance 
Background 
Optimal pain management in the Emergency Department remains problematic[1]. 
NSAID are a particularly useful class of drugs in Emergency Departments because of 
their effectiveness and safety[2].  The parenteral form of ketorolac has become 
particularly popular for treatment of acute pain in Emergency Departments, 
demonstrated by the total of more than 1100 doses given in the University of 
Missouri Emergency Department in January of 2018 (internal audit).  
 
Recently the optimal dosing of ketorolac has been questioned[3]. This study showed 
equal efficacy among three doses of intravenous ketorolac: the standard 30mg dose, 
15mg, and 10mg. These investigators recommended a change in practice to adopt the 
10mg dose as standard. 
 
Significance 
The correct dosing of analgesics and ketorolac is actually a complicated and poorly 
understood issue.  Ketorolac, as with other NSAID’s, has multiple properties that may 
influence its analgesic properties; it has anti-inflammatory properties similar to other 
NSAID, is an analgesic, and is an inhibitor of prostaglandin synthesis[2]. Also it has 
significant placebo effect in some circumstances. In a study of acute headaches in an 
Emergency Department three intramuscular injections were compared: meperidine 
50mg with 25mg promethazine, ketorolac 60mg, and saline[4].  The three treatments 
were found to be effective and equivalent.  The authors conclude that the placebo 
effect was so profound that analgesic effects could not be evaluated.  There is also 
evidence that ketorolac and other NSAID’s have different efficacy as a function of 


the type of pain[2]; that is, that pain which is inflammation medicated may be more 
very responsive.  
3.  
Objectives and Purpose 
This study is designed to determine the optimal dose of ketorolac in four groups of patients that 
would be expected to have different mechanisms of response to NSAID’s.  
 
4.  
Research Design and Methods 
 
Methods 
Patients presenting to the Emergency Department with  pain will be screened for 
inclusion into one of four groups: 
1. Headache: Non-traumatic headache of less than four days duration. 
2. Trauma: Patients with acute mild to moderate musculo-skeletal injury (no trauma 
activation) or pain of less than four days duration. 
3. Colic/Abdominal pain: Patients with mild to moderate abdominal or flank pain of 
less than four days duration. 
4. Viral syndrome: Patients with less than four days of generalized systemic 
complaints suggestive of an acute viral syndrome. 
A pregnancy test will be administered to females of childbearing potential before 
administration of the study drug.  Patients will be randomized to receive either 30mg 
of ketorolac, 10mg of ketorolac, or saline as a slow intravenous infusion over 10 
minutes via a pump.  Thirty minutes or later their pain score will be re-evaluated, they 
will be assessed for any negative effects of the treatment, additional pain medications 
will be offered if indicated, and the patient’s involvement in the study will be 
concluded. 
Data collected: 
1. Patient demographics 
a. Age 
b. Sex 
c. Complaint 
2. Pain scores 
3. Side effects noted by patient or staff 
 
5.   
Subjects 
Subjects will be eligible for recruitment when they present to the Emergency Department with a 
chief complaint consistent with the four study groups.  Inclusion criteria will be: 


 
1. Age≥18y/o 
 
2. Not pregnant or lactating (negative urinary pregnancy test) 
 
3. No contraindication to ketorolac 
Exclusion criteria 
 
1. Age<18y/o 
 
2. Pregnancy or lactation 
 
3. Contraindication to ketorolac 
If the subjects are eligible for inclusion they will be offered inclusion in the study by one of the 
Emergency Department faculty.  If they refuse participation they will be treated in a standard 
fashion. 
 
6. 
Treatment of subjects 
There will be no long term follow up of patients for data. Subjects who have incomplete data will 
have their data discarded and removed from enrollment. 
 
7. 
Statistics 
End point: the primary hypothesis is that ketorolac has different effects depending on the dose 
and the condition. We will compare pain scores at 30 minutes or after for each of the doses and 
the groups. 
Sample size: We plan to enroll 170 patients in each group.  This is based on a change in pain 
scale of 2.5 with a standard deviation of 2.5, and αof 0.05 and power of 0.80[5].  
An interim analysis will be performed when half of the patients are enrolled in each group.  The 
study will be terminated if there is significant difference in the groups at this point.  Dr. Chelsea 
B. Deroche is providing statistical support for the project. 
8. 
Direct access to source data/documents 
Access to source data and documents will be provided by the investigators for any auditing or 
monitoring or reviews by the IRB/IEC, or regulatory inspections. 
 
9. 
Ethics 
This trial proposes to the study the proper dosing of ketorolac in several different conditions and 
attempts to clarify the placebo effect in this setting.  Standard care will not be withheld at any 
time during this protocol.  The intervention may offer significant benefit for the patients being 
studied.  An interim analysis is planned with termination of the study if this is the case. 
 


10. 
Data handling and recordkeeping 
 
Initial data collection will include identification of the patient by name and medical recorded 
number.  This data will be kept in a locked cabinet in the Emergency Medicine Department.  
Data will be extracted from these records and recorded in a computer data base and identified 
only by subject number.  No patient identifies will be entered in to the computer database. 
 
11. 
Investigators 
Starr-Mar’ee Bedy: Dr. Bedy in Pharm.D. with extensive training in the clinical use of the 
medications involved in this study and a history of working in the emergency department.  
 
Kara Goddard: Dr. Goddard in Pharm.D. with extensive training in the clinical use of the 
medications involved in this study whose clinical duties are in the Emergency Department. 
 
Matthew Robinson:  Dr. Robinson is an Associate Professor of Emergency Medicine. He is 
attending physician in the Emergency Department and routinely manages patients with headache. 
 
Julie Stilley: Dr. Stilley is Research Assistant Professor in the Department of Emergency 
medicine and has extensive training in research. 
 
 
 
12.  
Financing and insurance 
 
Patients will have regular charges for Emergency Department visit but will not be charged for 
ketorolac/placebo or its administration.  Charges for any treatment will be per usual.  There will 
be no payments to the subjects. 
 
13. 
References 
 
1. 
Patrick, P.A., et al., Timely pain management in the emergency department. Journal of 
Emergency Medicine, 2015. 48(3): p. 267-73. 
2. 
Catapano, M.S., The analgesic efficacy of ketorolac for acute pain. Journal of Emergency 
Medicine, 1996. 14(1): p. 67-75. 
3. 
Motov, S., et al., Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for 
Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Annals of 
Emergency Medicine, 2017. 70(2): p. 177-184. 
4. 
Harden, R.N., et al., The placebo effect in acute headache management: ketorolac, meperidine, 
and saline in the emergency department. Headache, 1996. 36(6): p. 352-6. 
5. 
Glantz, S.A., Primer of biostatistics. 7 ed. 2012: McGraw-Hill. 
 


 
 
________________________________________    ______________________ 
Signature                                                                              Date 
Matthew Robinson, MD, Emergency Medicine Department, University of Missouri-Columbia