Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04246554
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ACL Injury; Postoperative Pain	Drug: Ketorolac; Drug: Oxycodone-Acetaminophen	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
• Actual Study Start Date: May 21, 2019
• Actual Primary Completion Date: Oct 9, 2020
• Actual Study Completion Date: Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery	Drug: Oxycodone-Acetaminophen; Oral oxycodone-acetaminophen for post-operative pain control
Experimental: Ketorolac 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	Drug: Ketorolac; Oral ketorolac for pain control following ACL reconstruction surgery

Outcome Measures

Primary Outcome Measures

1. Postoperative Visual Analogue Scale Scores [Up to 8 weeks postoperative]

   Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.

Secondary Outcome Measures

1. Narcotic Medication [5 days]

   Number of oxycodone-acetaminophen tablets

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients between 18 and 89 years old

• Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria:

• Patients below age 18 or above age 89

• Illiterate or non-English speaking individuals

• Patients with contraindications to Ketorolac

• History of chronic alcohol or drug abuse

• Chronic use of psychotropic or analgesic drugs

• Known peptic ulcer disease or bleeding diasthesis

• Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)

• Breastfeeding women

• Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UH Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Michael Karns, MD, University Hospital Cleveland Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 9, 2019
• Informed Consent Form - May 21, 2019

More Information

Publications

None provided.

• Responsible Party: Michael Karns, MD., Principal Investigator, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT04246554
• Other Study ID Numbers: STUDY20180985
• First Posted: Jan 29, 2020
• Last Update Posted: Dec 21, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Michael Karns, MD., Principal Investigator, University Hospitals Cleveland Medical Center: ACL reconstruction; Ketorolac; Pain; Narcotic
• Additional relevant MeSH terms: Pain, Postoperative; Anterior Cruciate Ligament Injuries; Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone

Study Results

Participant Flow

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control	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 Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery
Period Title: Overall Study
STARTED	26	23
COMPLETED	26	22
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Control	Ketorolac	Total
Arm/Group Description	Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control	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 Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery	Total of all reporting groups
Overall Participants	26	22	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	26 100%	22 100%	48 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.04 (12.98)	31.91 (9.96)	31.98 (11.57)
Sex: Female, Male (Count of Participants)
Female	17 65.4%	12 54.5%	29 60.4%
Male	9 34.6%	10 45.5%	19 39.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	26 100%	22 100%	48 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.18 (6.19)	28.03 (7.57)	28.11 (6.80)
Smoker (Count of Participants)
Count of Participants [Participants]	5 19.2%	3 13.6%	8 16.7%

Outcome Measures

1. Primary Outcome

Title	Postoperative Visual Analogue Scale Scores
Description	Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.
Time Frame	Up to 8 weeks postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control	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 Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery
Measure Participants	26	23
Mean (Standard Error) [score on a scale]	50.4 (5.3)	40.0 (4.9)

2. Secondary Outcome

Title	Narcotic Medication
Description	Number of oxycodone-acetaminophen tablets
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control	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 Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery
Measure Participants	26	23
Mean (Standard Error) [tablets]	12.4 (1.4)	5.5 (1.3)

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Control		Ketorolac
Arm/Group Description	Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery Oxycodone-Acetaminophen: Oral oxycodone-acetaminophen for post-operative pain control		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 Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery
All Cause Mortality
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/22 (0%)
Serious Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/26 (100%)		22/22 (100%)
Gastrointestinal disorders
nausea/ vomitin	5/26 (19.2%)	5	5/22 (22.7%)	5
abdominal pain	1/26 (3.8%)	1	1/22 (4.5%)	1
diarrhea	0/26 (0%)	0	0/22 (0%)	0
constipation	3/26 (11.5%)	3	4/22 (18.2%)	4
indigestion	0/26 (0%)	0	3/22 (13.6%)	3
Nervous system disorders
dizzy	5/26 (19.2%)	5	2/22 (9.1%)	2
drowsy	11/26 (42.3%)	11	6/22 (27.3%)	6
headache	2/26 (7.7%)		1/22 (4.5%)	1
Vascular disorders
bleeding	0/26 (0%)	0	0/22 (0%)	0

Limitations/Caveats

This is a single-institution study involving only five surgeons, so patient demographics and outcomes may not reflect a broader population. Neither surgeons nor patients were blinded with regards to medication use. Therefore, subjective pain scores may have been influenced by perceptions of greater pain control in patients who received ketorolac in addition to oxycodone-acetaminophen. The study may be underpowered with regards to functional outcome scores and medication side effects profiles.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.