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

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04246541
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The utilization of arthroscopic surgery to treat meniscus 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 a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.

Condition or Disease	Intervention/Treatment	Phase
Meniscus Tear, Tibial; Pain, Postoperative; Postoperative Complications; Ketorolac Adverse Reaction; Opioid Use	Drug: Ketorolac; Drug: Oxycodone-Acetaminophen	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 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 Meniscus Surgery
• Actual Study Start Date: Apr 23, 2019
• Actual Primary Completion Date: Sep 12, 2021
• Actual Study Completion Date: Sep 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery	Drug: Oxycodone-Acetaminophen; Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
Experimental: Ketorolac Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.	Drug: Ketorolac; Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.

Outcome Measures

Primary Outcome Measures

1. Pain Levels Recorded With a Visual Analogue Scale [2 weeks postoperatively]

   Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level.

2. Narcotic Medication Consumed [up to 5 days postoperatively]

   Number of oxycodone- acetaminophen tablets consumed

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 of age

• Patients undergoing primary arthroscopic meniscus surgery

Exclusion Criteria:

• Patients age less than 18 or greater than 89 years

• Illiterate or non-English speaking patients

• Patients with contraindications to ketorolac

• History of drug or alcohol abuse

• Chronic use of analgesic or psychotropic drugs

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 Hospitals Cleveland Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 27, 2019
• Informed Consent Form - Feb 25, 2020

More Information

Publications

None provided.

• Responsible Party: Michael Karns, MD., Principal Investigator, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT04246541
• Other Study ID Numbers: STUDY20181100
• First Posted: Jan 29, 2020
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• 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: ketorolac; meniscus tear; analgesics; pain
• Additional relevant MeSH terms: Pain, Postoperative; Postoperative Complications; Tibial Meniscus Injuries; Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone

Study Results

Participant Flow

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.	Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
Period Title: Overall Study
STARTED	25	23
COMPLETED	22	20
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Control	Ketorolac	Total
Arm/Group Description	Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.	Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.	Total of all reporting groups
Overall Participants	25	23	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	23 100%	48 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.9 (15.6)	47.9 (13.1)	47.9 (14.3)
Sex: Female, Male (Count of Participants)
Female	13 52%	11 47.8%	24 50%
Male	12 48%	12 52.2%	24 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	25 100%	23 100%	48 100%
Region of Enrollment (participants) [Number]
United States	25 100%	23 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Pain Levels Recorded With a Visual Analogue Scale
Description	Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level.
Time Frame	2 weeks postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.	Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
Measure Participants	25	23
Mean (Standard Deviation) [score on a scale]	25.6 (22.7)	28.8 (26.3)

2. Primary Outcome

Title	Narcotic Medication Consumed
Description	Number of oxycodone- acetaminophen tablets consumed
Time Frame	up to 5 days postoperatively

Outcome Measure Data

Analysis Population Description

9 subjects, including 4 in the control group and 5 in the ketorolac group, failed to report complete data on postoperative number of oxycodone-acetaminophen tablets consumed and were therefore excluded from data analysis.

Arm/Group Title	Control	Ketorolac
Arm/Group Description	Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.	Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
Measure Participants	21	18
Mean (Standard Deviation) [tablets]	5.7 (7.2)	3.5 (3.7)

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Control		Ketorolac
Arm/Group Description	Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.		Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
All Cause Mortality
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)
Serious Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Control		Ketorolac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)

Limitations/Caveats

single institution study not blinded

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.