Trial Outcomes & Findings for Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery (NCT NCT04246554)
NCT ID: NCT04246554
Last Updated: 2021-12-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
49 participants
Primary outcome timeframe
Up to 8 weeks postoperative
Results posted on
2021-12-21
Participant Flow
Participant milestones
| Measure |
Control
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
|
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
Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=26 Participants
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
|
Ketorolac
n=22 Participants
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
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=26 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=26 Participants
|
22 Participants
n=22 Participants
|
48 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=48 Participants
|
|
Age, Continuous
|
32.04 years
STANDARD_DEVIATION 12.98 • n=26 Participants
|
31.91 years
STANDARD_DEVIATION 9.96 • n=22 Participants
|
31.98 years
STANDARD_DEVIATION 11.57 • n=48 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=26 Participants
|
12 Participants
n=22 Participants
|
29 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=26 Participants
|
10 Participants
n=22 Participants
|
19 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
22 participants
n=22 Participants
|
48 participants
n=48 Participants
|
|
BMI
|
28.18 kg/m^2
STANDARD_DEVIATION 6.19 • n=26 Participants
|
28.03 kg/m^2
STANDARD_DEVIATION 7.57 • n=22 Participants
|
28.11 kg/m^2
STANDARD_DEVIATION 6.80 • n=48 Participants
|
|
Smoker
|
5 Participants
n=26 Participants
|
3 Participants
n=22 Participants
|
8 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeks postoperativePatients 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.
Outcome measures
| Measure |
Control
n=26 Participants
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
|
Ketorolac
n=23 Participants
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
|
|---|---|---|
|
Postoperative Visual Analogue Scale Scores
|
50.4 score on a scale
Standard Error 5.3
|
40.0 score on a scale
Standard Error 4.9
|
SECONDARY outcome
Timeframe: 5 daysNumber of oxycodone-acetaminophen tablets
Outcome measures
| Measure |
Control
n=26 Participants
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
|
Ketorolac
n=23 Participants
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
|
|---|---|---|
|
Narcotic Medication
|
12.4 tablets
Standard Error 1.4
|
5.5 tablets
Standard Error 1.3
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Ketorolac
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=26 participants at risk
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
|
Ketorolac
n=22 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
nausea/ vomitin
|
19.2%
5/26 • Number of events 5 • 6 weeks
|
22.7%
5/22 • Number of events 5 • 6 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
3.8%
1/26 • Number of events 1 • 6 weeks
|
4.5%
1/22 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/26 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
|
Gastrointestinal disorders
constipation
|
11.5%
3/26 • Number of events 3 • 6 weeks
|
18.2%
4/22 • Number of events 4 • 6 weeks
|
|
Gastrointestinal disorders
indigestion
|
0.00%
0/26 • 6 weeks
|
13.6%
3/22 • Number of events 3 • 6 weeks
|
|
Vascular disorders
bleeding
|
0.00%
0/26 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
|
Nervous system disorders
dizzy
|
19.2%
5/26 • Number of events 5 • 6 weeks
|
9.1%
2/22 • Number of events 2 • 6 weeks
|
|
Nervous system disorders
drowsy
|
42.3%
11/26 • Number of events 11 • 6 weeks
|
27.3%
6/22 • Number of events 6 • 6 weeks
|
|
Nervous system disorders
headache
|
7.7%
2/26 • 6 weeks
|
4.5%
1/22 • Number of events 1 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place