Trial Outcomes & Findings for Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery (NCT NCT04246541)
NCT ID: NCT04246541
Last Updated: 2022-03-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
2 weeks postoperatively
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
Control
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Baseline characteristics by cohort
| Measure |
Control
n=25 Participants
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.
|
Ketorolac
n=23 Participants
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
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
47.9 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks postoperativelyPatients 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.
Outcome measures
| Measure |
Control
n=25 Participants
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.
|
Ketorolac
n=23 Participants
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.
|
|---|---|---|
|
Pain Levels Recorded With a Visual Analogue Scale
|
25.6 score on a scale
Standard Deviation 22.7
|
28.8 score on a scale
Standard Deviation 26.3
|
PRIMARY outcome
Timeframe: up to 5 days postoperativelyPopulation: 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.
Number of oxycodone- acetaminophen tablets consumed
Outcome measures
| Measure |
Control
n=21 Participants
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.
|
Ketorolac
n=18 Participants
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.
|
|---|---|---|
|
Narcotic Medication Consumed
|
5.7 tablets
Standard Deviation 7.2
|
3.5 tablets
Standard Deviation 3.7
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Karns
University Hospitals Cleveland Medical Center
Phone: 216-844-7200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place