Clinical trial NCT04246554
Conditions: ACL Injury Postoperative Pain
Keywords: ACL reconstruction Ketorolac Pain Narcotic
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2019-05-21; Completion date: 2021-01-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery.
2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following ACL reconstruction surgery.

Detailed description:

Arms: arm 1: Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery arm 2: Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control
Interventions: intervention 1: Ketorolac intervention 2: Oxycodone-Acetaminophen
Intervention descriptions: intervention 1: Oral ketorolac for pain control following ACL reconstruction surgery intervention 2: Oral oxycodone-acetaminophen for post-operative pain control

Protocol documents:
Prot_SAP_000.pdf: 
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PROTOCOL TITLE:
Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following Arthroscopic 
Anterior Cruciate Ligament Surgery
PRINCIPAL INVESTIGATOR:
Michael R. Karns, M.D.
Orthopaedic Surgery
216-844-7200
Michael.Karns@uhhospitals.org
OTHER DEPARTMENTS INVOLVED IN THIS STUDY (IF APPLICABLE):    
☒  N/A   
VERSION NUMBER:
1
DATE: 
5/9/2019 


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Objectives 
1.
We aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of 
care pain protocol for postoperative pain control following arthroscopic anterior cruciate ligament 
surgery. 
2.
We hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain 
protocol will reduce postoperative opioid consumption following arthroscopic anterior cruciate ligament 
surgery.
Background
The utilization of arthroscopic surgery to treat anterior cruciate ligament injuries has continued to 
increase in recent years, partly due to a younger, more active population, and improved technology and 
technique. However, pain management in the post-operative period is critical to the ability to perform 
this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred 
analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side 
effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a 
significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid 
epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain 
modalities in the acute postoperative period. Ketorolac is an NSAID with analgesic and anti-inflammatory 
properties.1 Multiple prior studies have examined the beneficial effect of oral and IV ketorolac as an 
analgesic in the postoperative period,1-3 including ACL reconstruction surgery.4-6 However, the 
beneficial effects of this agent following arthroscopic anterior cruciate ligament surgery have not been 
extensively studied. 
Inclusion and Exclusion Criteria
At University Hospitals, patients in the practices of the orthopaedic investigators meeting the below 
inclusion and exclusion criteria will be eligible for enrollment in this investigation.  Patients will be 
evaluated for potential inclusion in the office setting during pre-operative discussion. Patients will be 
evaluated for exclusion criteria before enrollment. The patient’s past medical history will be evaluated 
for contraindications to ketorolac and the other exclusion criteria. A patient’s medical record and the 
pre-operative history form will be reviewed to ensure the patient does not meet any of the exclusion 
criteria. The patient will also be questioned prior to enrollment about having any of the conditions in the 
exclusion criteria using the questions on the patient enrollment form created for this study (see “Other 
Documents” in Sparta submission).
 
Inclusion Criteria
1.
Patients between the ages of 18 and 89 years old, male or female
2.
Patients undergoing primary arthroscopic anterior cruciate ligament surgery
3.
4.
Exclusion Criteria
1.
Patients below the age of 18 or above the age of 89
2.
Illiterate or non-English speaking patients


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3.
Patients with contraindications to Ketorolac
4.
History of alcohol or drug abuse
5.
Chronic use of analgesic or psychotropic drugs
6.
Known peptic ulcer disease or bleeding diathesis
7.
Renal dysfunction (eGFR < 50 mL/min/1.73m2)
8.
Breastfeeding women
9.
Pregnant women
Number of Research Participants
We are seeking to enroll 43 patients in this single-center study.
Recruitment Methods 
Patients will only be approached about study enrollment in the outpatient clinics of the orthoapedic 
investigators after they have agreed to undergo arthroscopic anterior cruciate ligament surgery as part 
of the standard of care for their anterior cruciate ligament pathology.  
Patients will only be approached about study enrollment in the outpatient clinics of the orthoapedic 
investigators after they have agreed to undergo arthroscopic anterior cruciate ligament surgery as part 
of the standard of care for their anterior cruciate ligament pathology.  
The source of patients will be from the practices of the Drs. Karns, Voos, Goodfellow, and Salata.
Patients will be evaluated for potential inclusion in the research study based on meeting the above 
inclusion/exclusion criteria.  Patient must be between the ages of 18 to 89, and presenting with anterior 
cruciate ligament pathology amendable to arthroscopic surgery. Patients with a history of prior surgery 
to the knee will be excluded as no revision procedure will be included in the investigation.  
The orthopaedic investigators included in this investigation receives dozens of consults every week for 
orthopaedic injuries to the knee and pain secondary to anterior cruciate ligament pathology that require 
operative intervention.  As such, the investigators will have access to more than the required number of 
research participants required to appropriately power this investigation.  
Setting
The research will be conducted at University Hospitals-Cleveland Medical Center, UH Ahuja Medical 
Center, UH Richmond Medical Center, UH Mentor Health Center, UH Westlake Health Center, and UH 
Suburban Health Center. Recruitment will occur in the office setting of the orthopaedic investigators in 
outpatient clinics. The primary research location for University Hospitals will be at UH Cleveland Medical 
Center (11100 Euclid Ave., Cleveland, OH, 44106), UH Ahuja Medical Center (3999 Richmond Road., 
Beachwood, OH, 44122), UH Mentor Health Center (9000 Mentor Ave, Mentor, OH 44060), UH Richmond 
Medial Center (27100 Chardon Rd, Richmond Heights, OH 44143), or UH Westlake Health Center (960 
Clague Road., Westlake, Ohio 44145).
Consent Process
Consent will take place in the office setting prior to surgery at one of respective locations listed above.  
Prior to discussion of the investigation, the patient and family will be asked if they require time to 


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discuss with others their desire to participate in the study.  No coercion will be encountered by the 
patients to serve as a research subject, as patients will be fully able to refuse.  Patient may be free to 
refuse participation at any point in the study. At University Hospitals, and all participating institutions, 
only IRB-approved study personnel will all be a part of obtaining consent in the clinic setting.  All will be 
up to date on their CITI training.  The authors anticipate 10 minutes to discuss the study and patient 
involvement, with 5 minutes to answer questions regarding study participation, resulting in a total of 15 
minutes.  Patients will be informed that the decision to enroll in the study is entirely dependent on their 
willingness to participate and that no changes in their medical care will be experienced based on their 
decision to participate or not.  An unsigned consent will signify that the patient is not interested in 
enrollment in the study investigation.  Again, it will be emphasized to the patients that no changes 
during surgery or in medical management during the post-operative time will be experienced based on 
the patient’s decision. Investigators obtaining consent will ensure adequate understanding by asking 
patients if they have any questions or concerns and if they understand the investigation being 
performed. All patients who enroll in the study will sign their consent form in the presence of a UH IRB-
approved study team member.
Sharing of Results with Research Participants
☒  Results will not be shared with research participants
☒  Results will not be shared with research participants’ doctors
Study Design
This is a prospective randomized clinical study that involves studying ketorolac as an adjuvant pain 
medication for arthroscopic anterior cruciate ligament surgery patients. All patients enrolled in this study 
will receive the standard pain control protocol before, during, and after surgery. This includes a 1) a 
regional block during the pre-operative period, 2), IV Dexamethasone and IV Odansetron during surgery, 
and 3) analgesics (as directed by the anesthesiologist) in the PACU. Both groups will also receive the 
standard of care discharge pain medications for arthroscopic anterior cruciate ligament surgery: 
oxycodone-acetaminophen 5-325 (1-2 tablets PO q4-6h PRN for moderate to severe pain #28 tabs). 
Patients will be randomized into one of two groups. Randomization would be performed using a pre-
defined computer-generated randomization sheet. Patients will not be randomized into a group until 
they are in the preoperative holding area. Patients will not be made aware of their randomization until 
postoperative. Patients will also Group 1 will receive standard of care pain protocol, including a 
prescription for oxycodone-acetaminophen 5-325 on discharge. Group 2 will also receive the standard of 
care pain protocol before, during, and after surgery but will also receive an intraoperative dose of IV 
ketorolac at the completion of the procedure and oral ketorolac on discharge (10mg PO q6 x3 days). 
Patients in this group will also be given omeprazole (20 mg PO, once per day x3 days). Patients will 
record their pain levels, oxycodone-acetaminophen 5-325 consumption, and pain medication side effects 
in a diary three times per day for the first five days after surgery. The patient will return the completed 
diary to their surgeon at the first post-operative appointment. Participation in this study will not require 
any additional visits to the surgeon’s office or hospital outside of the standard pre- and post-operative 
appointments.
Study Procedures


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1. All patients scheduled to undergo elective arthroscopic anterior cruciate ligament surgery identified in 
the office of one of the orthopaedic investigations will undergo the process of obtaining consent prior to 
surgery.  The consent form will be reviewed in depth with an IRB approved-member of the research 
team, all questions answered, and written consent obtained by the patient after all questions have been 
answered and the patient demonstrates a full understanding of the investigation and their role in the 
study. The patient’s home medications will be reviewed, and any potential drug-drug interactions will be 
discussed with the patient.     
2.  As part of the standard of care, patients undergoing elective arthroscopic anterior cruciate ligament 
surgery will undergo pre-operative testing to ensure patients are optimized for surgery from a medical 
perspective. During the pre-operative testing period, the standard blood draw taken as part of the 
standard of care, utilizing no more of the patient’s time or blood than generally performed if the patient 
were not enrolled in the investigation. Before surgery patients will fill out the following patient reported 
outcome metrics: Visual Analogue Score (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), 
International Knee Documentation Committee (IKDC) evaluation, and the Lysholm knee score. It is 
expected that it will take the subject about 5-10 minutes to complete these questionnaires.
3.  Patients will be re-identified in the preoperative holding area. Both Group 1 and Group 2 will receive 
the standard of care pain protocol for arthroscopic anterior cruciate ligament surgery, which consists of: 
1) IV Dexamethasone and IV Odansetron during surgery, and 2) analgesics (as directed by the 
anesthesiologist) in the PACU. Both groups will also receive the standard of care discharge pain 
medications for arthroscopic anterior cruciate ligament surgery: oxycodone-acetaminophen 5-325 (1-2 
tablets PO q4-6h PRN for moderate to severe pain #28 tabs). Group 1 will receive only the standard of 
care pain protocol on the day of their surgery and discharge pain medications. Group 2 will receive the 
standard of care pain protocol on the day of surgery and an intraoperative dose of IV ketorolac at the 
completion of surgery (dosing individualized by patient age and weight). The operating surgeon will be 
responsible for directing the anesthesiologist to administer the IV Ketorolac. Group 2 will also receive the 
standard of care discharge pain medications and scheduled oral ketorolac (10mg PO q6 x3 days). In 
addition, all Group 2 patients will receive a prescription for omeprazole (20 mg PO, once per day x3 days) 
to take for 3 days after surgery to decrease their risk of developing stomach ulcers. Patients in Group 1 
will not receive a prescription for omeprazole. A 1:1 randomization ratio will be used (an equal number 
of patients will be placed in each group). Patients will then undergo standard arthroscopic anterior 
cruciate ligament surgery with one of the surgical investigators. Prior to discharge, all patients will be 
provided a handout on safely using opioids.  
4. Following discharge from the ambulatory surgery center, patients in Group 1 and Group 2 will be 
asked to document their VAS pain scores at 6 hour intervals (morning, afternoon, and evening) for five 
days in a journal administered to them at the time of study enrollment. They will also be asked to record 
the number of oxycodone-acetaminophen 5-325 pills they take during this time interval in their journal. 
At the end of each day, patients will be asked to document the following adverse effects: nausea, 
vomiting, somnolence, dizziness, headache, pain, pruritis, other in their journal. All patients in Group 2 
will be instructed to take ketorolac every 6 hours for pain every day for the first 3 days after surgery. 
Thus, patients in Group 2 will not be required to record the number of ketorolac pills they take each day. 
To ensure safety, all patients assigned to Group 2 will receive a form outlining the common and serious 
side effects of Ketorolac and specific instructions for when they should call their doctor or go to the 
emergency room. All patients who receive anterior cruciate ligament surgery at UH are instructed to call 
their surgeon’s office if they feel their pain is not controlled at home after surgery. 


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5. Patients in Group 1 and Group 2 will receive a phone call from a member of the study team on Day 2 
after surgery to see if they have any questions and to ensure they are filling out their journal. Patients in 
Group 2 will also be asked if they are experiencing any of the side effects from ketorolac. Patients in 
Group 2 will be given an educational handout on the side effects of ketorolac when they are discharged 
from the hospital.
6.  Patients will follow up in clinic on a routine basis based on the recommendations of the surgeon, 
typically at 1-2 weeks, 6 weeks, 3 months, 6 months and 1 year following surgery.  During these follow 
up appointments, patients will be screened per standard of care for range of motion to the operative 
knee, pain levels, strength and questioned regarding functionality of the operative knee.  In the setting of 
a complication (wound breakdown, infection), patient information will be recorded and communicated 
using university password protected email to communicate with the primary investigator. At the first two 
follow-up clinic appointment after surgery, patients will fill out the following patient reported outcome 
metrics: VAS, KOOS, IKDC, and Lysholm questionnaires. The first appointment is about 1-2 weeks after 
surgery and the second appointment is about 6-8 weeks after surgery. Filling out these questionnaires 
should only take 5-10 minutes to complete at each clinic visit.
7. After 1 month from their surgery date, patients will receive a phone call from a member of the study 
team to ask how many refills they have received for their prescription for oxycodone-acetaminophen 5-
325. After the second follow-up appointment, the subjects participation in the research will be complete.
Study Timeline
Patients are evaluated in the orthopaedic investigators’ outpatient clinics for anterior cruciate ligament 
pathology. If a patient’s condition is amenable to arthroscopic surgery and they elect to undergo the 
procedure they will be approached for participation in this study. This evaluation and discussion of the 
surgical procedure should take 10-15 minutes. The time for enrolling a patient should take 10 minutes 
with 5 minutes for patients’ questions. Therefore, an outpatient visit for a patient enrolling this study 
would take 25-30 minutes. This will be the only visit before surgery. After the surgery, patients will 
complete their pain diaries at home each day, which should take about 5 minutes each day to fill in. They 
will bring these completed diaries to their first post-op visit. 
Data to be Collected for your study 
(AFTER consent and HIPAA Authorization have been obtained)
Name, dates, telephone number, MRN, 
Pre-operative diagnosis
•
Mechanism of injury/disease, if relevant
•
Narcotic pain medication and side effects in patient journal (number of opioid pills consumed 
at six hour intervals for five days postoperative)
•
Pre- and post-operative scores for the following

Patient-Reported Outcomes Measurement Information System (PROMIS)
o
Visual Analog (VAS)
o
Knee injury and osteoarthritis outcome (KOOS)
o
International Knee Documentation Committee (IKDC)
o
Lysholm


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Data Analysis Plan
Statistically significant differences in patient demographics and comorbidities between Group 1 and 
Group 2 will be determined initially with univariate analysis. Students t-test will be utilized to compare 
the differences in mean VAS scores and narcotics utilization between the two groups at each time point. 
Linear regression models will be utilized to identify trends over time. Descriptive analyses (e.g., 
percentages) will be used to report qualitative data as appropriate. 
The minimal clinically important difference in VAS scores is 13 in patients with rotator cuff disease.4 A 
prior study by White et al.1 comparing oxycodone-acetaminophen versus oral ketorolac for analgesia 
following arthroscopic tubal ligation, the common standard deviation in VAS scores was 11 points. Only 
one published study, by Honig et al.,7 has reported pain levels after administering IV or oral ketorolac to 
patients undergoing anterior cruciate ligament surgery, with a common standard deviation in VAS scores 
of 13.3. Using this data, our power analysis showed that, with an alpha of 0.05 and 90% power, we 
would need 34 patients, or 17 per group, to achieve adequate power. However, to account for a 20% 
dropout rate we will recruit for 43 patients. Power analysis was performed using G*Power 3.1.9.2.
The primary endpoint of this study is VAS pain scores and number of narcotic medications consumed. 
Secondary scores include, KOOS, IKDC, Lysholm, and PROMIS scores.
Drugs or Devices
Ketorolac is an FDA-approved drug for pain relief. Omeprazole is an FDA-approved drug for the prevention 
and treatment of gastroesophageal reflux disease (GERD). 
Patients randomized to Group 2 will be provided IV and oral ketorolac during the study, as well as oral 
omeprazole. The IV ketorolac will be provided by the anesthesia team in the operating room at the 
conclusion of the study. The study investigators will provide patients with a prescription for the oral 
ketorolac and oral omeprazole, which they may fill at a pharmacy of their choice.
Confidentiality 
Data collected from subjects participating in the study will be immediately protected as each subject will 
be assigned a number based on their enrollment and the institution in which they were enrolled that will 
in no way correspond to any pertinent data relating to the subject’s protected health information. 
Following the results of lab studies and follow up appointments, all data will be entered electronically 
into RedCap software. Electronic copies of any documentation will be stored in the UH Secure Network 
drive or UH Encrypted Drive (Iron Key) while any physical documentation be placed within the locked file 
cabinets located within the institution’s investigators office.  Data will be accessed by only approved 
study personnel.   Data will be assessed for completeness, accuracy and per strict adherence to the 
approved protocol by the orthopaedic resident (LS) and during bi-monthly meetings with the 
investigative team who will be responsible for data protection using files on only protected hospital 
computers.  In addition, monitoring of the data by the entire investigative team will be conducted 
frequently during these bi-monthly meeting in which the standards and rules of the protocol will be 
reviewed to ensure that all regulations set forth in the confidentiality agreement are met and complete.  
Following the complete data transfer electronically, all documentation will be properly disposed of to 
ensure complete participant protection of information.  Following the conclusion of the study, all 


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documentation will be disposed of while maintaining patient confidentiality for 3 years following study 
closure per UH policy.  
Risks to Research Participants
All patients scheduled for elective arthroscopic anterior cruciate ligament surgery undergo pre-operative 
testing to ensure they are medically optimized for surgery. Patients with contraindications to Ketorolac 
will not be enrolled in the study:

Previous allergic reaction to Ketorolac

History of any of the following: peptic ulcer disease, gastrointestinal bleeding, or perforation of 
the stomach or bowel

Having experienced an asthma, urticarial, or a allergic-type reactions after taking aspirin or 
other NSAIDs

History of kidney disease or kidney failure

History of a brain bleed

History of a bleeding disorder

Currently taking the medication probenecid

Currently taking the medication pentoxifylline
The investigators will ensure no patient with contraindications to Ketorolac are enrolled via the 
following: 1) the patient’s past medical history in their electronic medical record and pre-operative 
history form will be evaluated for contraindications to ketorolac, and 2) the patient will be questioned 
prior to enrollment about having any of the conditions that are contraindications to Ketorolac using the 
patient enrollment form created for this study (see “Other Documents” in Sparta submission). 
Common non-serious side effects of Ketorolac:
•
Nausea, stomach pain, indigestion, diarrhea
•
Dizziness, drowsiness
•
Headache
•
Swelling
Serious side effects of Ketorolac:
•
Gastrointestinal problems: ulcers, bleeding, or peforation
•
Hemorrhage
•
Impaired renal function
•
Impaired liver function
•
Allergic or anaphylactoid reaction
•
Anemia
•
Ketorolac, like other NSAIDs, may cause serious cardiovascular side effects, such as 
myocardial infarction or stroke, which may result in hospitalization and even death
All patients that receive ketorolac will be monitored in the PACU for side effects to Ketorolac after 
receiving an IV dose at the end of their surgery, and will be given an informative handout on ketorolac 
and its side effects (see “Other Documents” in Sparta submission). This handout also has instructions for 
when patients should call their surgeon’s office or seek immediate medical assistance. In addition, all 
patients enrolled in this study will receive a phone call on Day 2 after surgery to ensure they are filling 


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out their pain diary. Patients who received ketorolac will also be questioned about having any side 
effects of ketorolac.
Also, enrollment in the investigation does increase the risk for breach of confidentiality during subject 
enrollment in study.
Provisions to Protect the Privacy Interests of Research Participants
Privacy of the study subjects will be protected throughout all phases of the research study.  Consent will 
be obtained by only a member of the investigative team and patients will be given the opportunity to 
discuss participation with an investigator out of the room, allowing the patient to remain alone or with 
family.  During the study period, all subject data will be protected through careful handling of patient 
information by assigning each subject a research number.  After completion and collection of all study 
documents, all documentation will then be securely transported back to the appropriate investigators 
office securely locked away after being entered electronically after the identifiable information is 
converted to a study number which will not contain any protected health information. All patient 
information will be stored confidentially on protected hospitals computers and files using RedCap 
software to ensure added protection.  Following conclusion of the study, all hard documentation will be 
stored within the locked file cabinet in the investigators office after being transferred onto electronic files 
protected by RedCap.  All documentation will be disposed of at the end of the study to ensure 
confidentiality is maintained.  In addition, participants and their information will not be discussed in any 
public areas or with any medical or non-medical personnel not directly involved with and approved as an 
active investigative member of the research study. 
 
Potential Benefit to Research Participants
There is no guaranteed direct benefit from participating in the study. All subjects undergoing surgery will 
benefit from the known effects of arthroscopic anterior cruciate ligament surgery following surgery 
whether or not they are enrolled in the study.  Possible benefit of the research is patients could 
experience increased pain relief, compared to standard pain control protocols, after surgery from 
receiving intra-operative IV and PO Ketorolac. This will make their post-op period more comfortable.
Withdrawal of Research Participants
Patients can withdraw at any point during the study period.  Patients will be withdrawn if they fail to 
appropriately follow up in the post-operative period. If a patient withdraws from the study before their 
surgery, they will proceed with their arthroscopic anterior cruciate ligament surgery and clinical follow-
up, and no further data will be collected on them. If a patient withdraws during the post-operative 
period, then no more follow-up data will be collected past their withdrawal date.
Alternatives to Participation
Patients may elect to proceed with arthroscopic anterior cruciate ligament surgery with the standard of 
care postoperative pain regiment oxycodone-acetaminophen 5-325  (1-2 tabs PO q4-6h PRN moderate to 
severe pain #28 tabs))
Arthroscopic repair is a well-established treatment option for patients with anterior cruciate ligament 
pathology. Therefore, if their surgeon has recommended they receive arthroscopic repair, it will be 
because the surgeon believes it is the best treatment option for their condition, not for research 
purposes. If a patient elects to withdraw from the Ketorolac arm, they will simply be asked to discontinue 


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use of Ketorolac and continue with the use of oxycodone-acetaminophen 5-325. Since this is the standard 
of care there is no alternative treatment to list in the consent.
Costs to Research Participants
There are not sufficient funds within our department to cover the cost of ketorolac and omeprazole for 
patients randomized into Group 2. As such, the patient’s insurance company will be responsible for the 
cost of ketorolac and omeprazole. However, ketorolac is a generic drug that is commonly utilized both 
within and outside of Orthopaedics. Patients will ultimately be responsible if the insurance company does 
not pay, and for any associated co-pay. Paying for Ketorolac and Omeprazole will be discussed with the 
patient in clinic during the consent process.
Research Participant Compensation
There is no compensation for subjects.
Provisions to Monitor the Data to Ensure the Safety of Research Participants
Data collected from subjects participating in the study will be immediately protected as each subject will 
be assigned a number that will in no way correspond to any pertinent data relating to the subject’s 
protected health information. Following collection of data from questionnaires and pain journals, the 
orthopaedic resident will collect all documentation and after being entered electronically behind RedCap 
software, will be placed within the locked file cabinets located within the primary investigators office.  
Data will be accessed by only approved study personnel. Data will be assessed for completeness, 
accuracy and per strict adherence to the approved protocol by the orthopaedic resident and during bi-
monthly (once per two months) meetings with the investigative team who will be responsible for data 
protection using files on only protected hospital computers. In addition, monitoring of the data by the 
entire investigative team will be conducted frequently during these bi-monthly meeting in which the 
standards and rules of the protocol will be reviewed to ensure that all regulations set forth in the 
confidentiality agreement are met and complete. Recorded adverse/safety events will be actively 
monitored by the Orthopaedic Resident, and reviewed during the bi-monthly meetings. Any 
adverse/safety events identified through pain diaries and post-op day 2 follow-up calls will be 
documented in the regulatory binder and the PI of the study will be immediately informed, followed by 
reporting the events to the IRB. Following the complete data transfer electronically, all documentation 
will be properly disposed of to ensure complete participant protection of information.  Following the 
conclusion of the study, all information and hard copies will remain stored in a locked file cabinet located 
within the primary investigators office per UH policy.
References   
1.
White PF, Joshi GP, Carpenter RL, Fragen RJ. A comparison of oral ketorolac and hydrocodone-
acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation. 
Anesth Analg. 1997 Jul;85(1):37-43. Epub 1997/07/01.
2.
Gebuhr PH, Soelberg M, Strauss W. A multiple-dose, double-blind comparison of intramuscularly 
and orally administered ketorolac tromethamine and Ketogan in patients with pain following 
orthopaedic surgery. J Int Med Res. 1994 Jul-Aug;22(4):202-17. Epub 1994/07/01.
3.
McQuay HJ, Poppleton P, Carroll D, Summerfield RJ, Bullingham RE, Moore RA. Ketorolac and 
acetaminophen for orthopedic postoperative pain. Clin Pharmacol Ther. 1986 Jan;39(1):89-93. Epub 
1986/01/01.


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4.
Barber FA, Gladu DE. Comparison of oral ketorolac and hydrocodone for pain relief after anterior 
cruciate ligament reconstruction. Arthroscopy. 1998 Sep;14(6):605-12. Epub 1998/10/01.
5.
Tierney GS, Wright RW, Smith JP, Fischer DA. Anterior cruciate ligament reconstruction as an 
outpatient procedure. Am J Sports Med. 1995 Nov-Dec;23(6):755-6. Epub 1995/11/01.
6.
Brown DW, Curry CM, Ruterbories LM, Avery FL, Anson PS. Evaluation of pain after 
arthroscopically assisted anterior cruciate ligament reconstruction. Am J Sports Med. 1997 Mar-
Apr;25(2):182-6. Epub 1997/03/01.

ICF_001.pdf: 
UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
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Version 1.0  Version Date: 5-9-19
Key Information: The following is a short summary of this study to help you decide whether 
or not to be a part of this study. More detailed information is listed later on in this form.
Why am I being invited to take part in a research study?
You are being asked to participate in this research study because you have a tear in your anterior 
cruciate ligament and are scheduled to have surgery to fix it. This research study is looking to 
potentially find new ways to improve pain control for patients who are having surgery to repair 
anterior cruciate ligament tears.
Things I should know about a research study
• Someone will explain this research study to you.
• Whether or not you take part is up to you.
• You can choose not to take part.
• You can agree to take part and later change your mind.
• Your decision will not be held against you.
• You can ask all the questions you want before you decide.
Introduction/Purpose
You are being asked to participate in a research study because you have damage to your anterior 
cruciate ligament and are scheduled to have a surgery to fix it. Arthroscopic surgery is a 
minimally invasive type of surgery that uses a small scope in your knee joint. Patients who have 
this type of surgery often have pain in their knee, especially during the days following surgery. 
The goal of this research study is to see if adding another drug, called Ketorolac (Trade name: 
Toradol), to the normal pain medicine you receive after surgery will help reduce the knee pain. 
Ketorolac is a non-steroid anti-inflammatory drug (NSAID) which means it can help relieve pain 
and reduce inflammation in the body. This drug is approved for short-term treatment of pain in 
adults. We will tell if this drug is effective by looking at your pain medication use and your pain 
levels during the days following surgery. You will be one of 43 people enrolled in this study here 
at University Hospitals.
Participating in research is voluntary, which means the choice is up to you. Choosing not to 
participate will have no effect on the medical care that you receive. This form, called a consent 
form, explains everything that will happen to you if you decide to participate. Please read it 
carefully and have all of your questions answered before you make your decision. If you decide 
to participate, we will have you sign this consent form. You will be given a copy of this form to 
keep.
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 2 of 9
Version 1.0  Version Date: 5-9-19
Key Study Procedures
Your participation in this study will last for about 2 months after your surgery. You will be 
assigned to a study group by chance using a process similar to the flip of a coin before you have 
your surgery. This process is called randomization. The first group (Group 1) will receive the 
standard pain medication before, during, and after surgery for arthroscopic anterior cruciate 
ligament surgery. The second group (Group 2) will receive the standard pain medication before, 
during, and after surgery but will also receive Ketorolac during surgery through the IV in the arm 
and will be given a Ketorolac prescription to take after leaving the hospital.
No matter what group you are in, you will fill out a pain diary at home for the first five days after 
surgery. You will fill out questionnaires that ask about your pain and function levels before 
surgery and at your first and second appointments after surgery. You will receive two phone calls 
from a member of the study team after surgery.
More detailed information about the study procedures can be found under “Detailed Study 
Procedures.”
Key Risks
There is a risk of breach of confidentiality for all patients in the study, which means that 
someone who is not listed in this form might view your data either by accident or from malicious 
actions they take to hack the data. We are protecting against this by only storing information that 
can be directly linked to you on UH computers, in password protected files which are behind 
firewalls.
If you are randomized to the group that receives Ketorolac (Group 2), there is a risk of you 
experiencing common side effects from the medication, which include, but are not limited to 
headache, dizziness, nausea, and drowsiness. Since Ketorolac is an NSAID, it can cause stomach 
ulcers or bleeding, kidney failure, allergic reactions, and increased risk for a heart attack or 
stroke. We will be closely monitoring you for symptoms of these side effects. Patients in Group 
2 will also receive Omeprazole to prevent stomach pain and decrease risk of stomach ulcers. 
There is a risk of experiencing common side effects from Omeprazole, which include, but are not 
limited to headache, vomiting, diarrhea, stomach pain, constipation, and fatigue. 
More detailed information about the risks of this study can be found under “Detailed Risks.”
Benefits
There may be no direct benefit to you by your participation in this research. However, your 
participation in this study may help us learn new information that can help improve how we care 
for our surgery patients in the future.
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 3 of 9
Version 1.0  Version Date: 5-9-19
Alternatives to Study Participation
Because of the nature of this study, the only alternative is to not participate in this study. You 
may choose not to participate in this study, and to have your surgery as planned. Your pain will 
be controlled using the normal, standard methods described to you by your doctor. If you decide 
to participate, you can change your mind at any time and stop participating. You just have to let 
us know.
Detailed Information: The following is more detailed information about 
this study in addition to the information listed above.
Detailed Study Procedures
During your standard pre-operative clinic visit, you will fill out standard questionnaires that ask 
about your pain and function level. These questionnaires should only take you 5 to 10 minutes to 
complete.
If you are randomized to Group 1, you will receive all of the standard pain medication before, 
during, and after surgery. This includes Oxycodone-Acetaminophen 5-325 (Percocet) pills to be 
taken every 4-6 hours by mouth as needed for moderate to severe pain after leaving the hospital. 
Patients in Group 1 will not receive Ketorolac or Omeprazole.
If you are randomized to Group 2, you will receive a dose of IV Ketorolac at the end of your 
surgery, and will be given Ketorolac pills to be taken by mouth every six hours for three days 
after leaving the hospital. We recommend that Ketorolac be taken with food or with an antacid to 
avoid stomach upset. In addition, you will be prescribed Omeprazole to be taken by mouth for to 
reduce your risk of developing peptic ulcer disease. The Omeprazole must be taken once daily 
for a total of three days. We also recommend that Omeprazole be taken with food. You will also 
be given two informative handouts on taking Ketorolac and its side effects. If randomized into 
Group 2, your insurance company will be responsible for the cost of the IV Ketorolac you 
receive during surgery, as well as the Ketorolac pills and Omeprazole pills.. If your insurance 
company does not cover the cost of the Ketorolac and Omeprazole, you will be responsible for 
the cost. In addition, you will be given prescriptions for Ketorolac and Omeprazole before 
leaving the hospital. It is your responsibility to fill these medications following discharge at a 
pharmacy of your choice.
After your surgery, you will have your follow up care just as you would if you did not participate 
in the study. This includes instructions on when to start physical therapy to help strengthen your 
knee after surgery. As part of this research study, we will give you a diary and ask you to write 
down how much pain you are having and how much pain medicine you need to take during the 
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 4 of 9
Version 1.0  Version Date: 5-9-19
morning, afternoon, and evening. At the end of the day you will write down if you have any side 
effects from the medicine like nausea, vomiting, drowsiness, or headaches. You will be asked to 
update this diary three times per day (morning, afternoon, and evening), every day for 5 days. 
Writing in this diary should only take 3 to 5 minutes to complete and can be done whenever you 
have time. At you first follow-up appointment in clinic, most likely 7-14 days after your surgery, 
you will fill out questionnaires that will ask you about your pain and functional levels after 
surgery. You will fill out these same questionnaires at your second follow-up appointment in 
clinic at about 6 to 8 weeks after surgery. During both clinic visits, filling out these 
questionnaires should only take you 5 to 10 minutes to complete.
You will receive two phone calls from a member of the study team after your surgery. The first 
phone call will be on the second day after surgery to make sure you have not had any problems 
with filling out your diary and to answer any questions you may have about the study. If you are 
in the group that received Ketorolac (Group 2), you will also be asked if you have experienced 
any side effects from taking Ketorolac. You will receive the second phone call approximately 1 
month from your surgery, and you will be asked how many refills you have had for your pain 
medicine prescription (Oxcodone-Acetaminophen 5-325) and if you have any remaining 
questions about the study. 
Detailed Risks
There is a risk that you may experience some side effects from Ketorolac such as: headache, 
dizziness, nausea, and drowsiness. Since Ketorolac is an NSAID, it can cause stomach ulcers or 
bleeding, kidney failure, allergic reactions, and increased risk for a heart attack or stroke. We 
will be closely monitoring you for symptoms of these side effects. There are no known risks or 
reported drug interactions for Ketorolac with the standard of care pain medicine used for 
arthroscopic rotator cuff surgery at University Hospitals.
If you feel your pain is not adequately controlled or if you are having any side effects from your 
pain medications, please call your surgeon’s office. These are standard instructions for all 
patients who receive anterior cruciate ligament surgery at University Hospitals.
There is a risk that you may experience side effects while taking Omeprazole such as: headache, 
vomiting, diarrhea, stomach pain, constipation, and fatigue. There is also the risk of developing 
an allergic reaction or symptoms of liver damage (yellow skin, dark urine, fatigue), but these are 
extremely rare. 
There is a risk that the drugs provided in this study may interact with the medications you take at 
home. Your home medications will be reviewed by your surgeon or study investigator and 
screened for any potential drug-drug interactions. 
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 5 of 9
Version 1.0  Version Date: 5-9-19
There is a risk of breach of confidentiality which means that someone who is not listed in this 
form might view your data either by accident or from malicious actions they take to hack the 
data. We are protecting against this by only storing information that can be directly linked to you 
on UH computers, in password protected files which are behind firewalls.
Financial Information
You will not be paid for your participation in this study. The surgery you will have is not a part 
of this research, and you or your insurance company will be responsible for the costs of your 
surgery. If you are randomized into Group 1, which receives the same pain medications as 
patients who are not enrolled in the study, there is no additional cost to you or your insurance 
company for participating in the study. Patients randomized into Group 2 will receive IV 
Ketorolac during their surgery and Ketorolac pills in addition to the standard pain medications 
after surgery. Patients in Group 2 will also receive a prescription for Omeprazole. If you are 
randomized into Group 2, you or your insurance company will be responsible for the cost of the 
Ketorolac medication, Omeprazole medication, and for any associated co-pay. 
Notice for Managed Care (Medicare Advantage Plan) Beneficiaries
Certain services provided to you as a participant in a clinical trial are allowable to be billed to, 
and paid by, your medical insurance. These services are referred to as “covered” clinical trial 
services. If you have a Medicare Advantage Plan as part of your medical insurance, the Centers 
for Medicare & Medicaid Services (CMS) require that traditional Medicare will be billed for 
those services. When this occurs, you will remain responsible for paying the coinsurance and 
deductibles according your Medicare Advantage Plan. Your Medicare Advantage Plan should 
cover any associated cost share related to Medicare. Please speak with a financial counselor to 
understand what the specific financial impact will be for you associated with participating in this 
clinical trial.
Research-Related Injury
If injury occurs as a result of your involvement in this research, medical treatment is available 
from University Hospitals or another medical facility but you/your medical insurance will be 
responsible for the cost of this treatment. A research injury is an injury that happens as a result of 
taking part in this research study. If you are injured by a medical treatment or procedure that you 
would have received even if you weren’t in the study, that is not considered a “research injury”. 
There are no plans for payment of medical expenses or other payments, including lost wages, for 
any research related injury. To help avoid injury, it is very important to follow all study 
directions.
Student/Employee Rights
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 6 of 9
Version 1.0  Version Date: 5-9-19
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor the will results be shared with your supervisor.
Confidentiality
All of the information we collect about you will be kept confidential. You will be assigned a 
unique study number and this number will be used to identify your data. Information that 
identifies you will only be accessed by members of the study team, and will be kept secure on 
protected University Hospitals computers or on a password encoded flash drive. Your 
information or samples that are collected as part of this research will not be used or distributed 
for future research studies, even if all of your identifiers are removed.
Privacy of Protected Health Information
The Health Insurance Portability & Accountability Act (HIPAA) is a Federal law that helps to 
protect the privacy of your health information and to whom this information may be shared 
within and outside of University Hospitals. This Authorization form is specifically for a research 
study entitled “Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior cruciate ligament Surgery” and will tell you what health information 
(called Protected Health Information or PHI) will be collected for this research study, who will 
see your PHI and in what ways they can use the information. In order for the Principal 
Investigator, Michael Karns, MD and the research study staff to collect and use your PHI, you 
must sign this authorization form. You will receive a copy of this signed Authorization for your 
records. If you do not sign this form, you may not join this study. Your decision to allow the use 
and disclosure of your PHI is voluntary and will have no impact on your treatment at University 
Hospitals. By signing this form, you are allowing the researchers for this study to use and 
disclose your PHI in the manner described below.
Generally the Principal Investigator and study staff at University Hospitals and Case Western 
Reserve University who are working on this research project will know that you are in a research 
study and will see and use your PHI. The researchers working on this study will collect the 
following PHI about you: your name, medical record number, your age, underlying medical 
diagnoses, height, weight and subjective pain tolerance. This PHI will be used to assess multiple 
outcome variables as they relate to pain in the knee after surgery. Your access to your PHI may 
be limited during the study to protect the study results.
Your PHI may also be shared with the following groups/persons associated with this research 
study or involved in the review of research: co-investigators, other staff from the Principal 
Investigator’s medical practice group; University Hospitals, including the Center for Clinical 
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 7 of 9
Version 1.0  Version Date: 5-9-19
Research and the Law Department; Government representatives or Federal agencies, when 
required by law.
Your permission to use and disclose your PHI does not expire. However, you have the right to 
change your mind at any time and revoke your authorization. If you revoke your authorization, 
the researchers will continue to use the information that they previously collected, but they will 
not collect any additional information. Also, if you revoke your authorization you may no longer 
be able to participate in the research study. To revoke your permission, you must do so in writing 
by sending a letter to: Michael Karns MD, Hanna House 6th Floor Department of Orthopaedic 
Surgery, 11100 Euclid Ave, Cleveland, Ohio 44106. If you have a complaint or concerns about 
the privacy of your health information, you may also write to the UH Privacy Officer, 
Management Service Center, 3605 Warrensville Center, MSC 9105, Shaker Heights, OH 44122 
or to the Federal Department of Health and Human Services (DHHS) at DHHS Regional 
Manager, Office of Civil Rights, US Department of Health and Human Services Government 
Center, JF Kennedy Federal Building, Room 1875, Boston, MA 02203. Complaints should be 
sent within 180 days of finding out about the problem.
The researchers and staff agree to protect your health information by using and disclosing it only 
as permitted by you in this Authorization and as directed by state and Federal law. University 
Hospitals is committed to protecting your confidentiality. Please understand that once your PHI 
has been disclosed to anyone outside of University Hospitals, there is a risk that your PHI may 
no longer be protected; however other Federal and State laws may provide continued protection 
of your information.
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary. Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If 
you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits. If information generated from this study is published or presented, your 
identity will not be revealed. In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating. If you experience 
physical injury or illness as a result of participating in this research study, medical care is 
available at University Hospitals Cleveland Medical Center (UHCMC) or elsewhere; however, 
UHCMC has no plans to provide free care or compensation for lost wages.
Disclosure of your study records
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 8 of 9
Version 1.0  Version Date: 5-9-19
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records. If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known.
Contact information
________________________________________ has described to you what is going to be done, 
the risks, hazards, and benefits involved. The Principal Investigator, Michael Karns, MD, can 
also be contacted at 216-844-0209. If you have any questions, concerns or complaints about the 
study in the future, you may also contact them later.
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-5633 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061.
Signature
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study. By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have. A copy of this consent form will be provided to you.
x
Signature of Participant                                                                                           Date
x
Printed Name of Participant
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v. 12.2018)
Project Title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control following 
Arthroscopic Anterior Cruciate Ligament Surgery
Principal Investigator:  Michael R. Karns, M.D.
Page 9 of 9
Version 1.0  Version Date: 5-9-19
x
Signature of person obtaining informed consent                                                    Date
x
Printed name of person obtaining informed consent 
    
        IRB NUMBER: STUDY20180985
        IRB APPROVAL DATE: 5/21/2019
        IRB EFFECTIVE DATE: 6/21/2019
        IRB EXPIRATION DATE: 5/20/2020