Trial Outcomes & Findings for Oral Ketorolac for Arthroscopic Rotator Cuff Repair (NCT NCT03967847)
NCT ID: NCT03967847
Last Updated: 2022-05-10
Results Overview
The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
participants were assessed at one single time point up to 8 weeks.
Results posted on
2022-05-10
Participant Flow
44 patients were enrolled/randomized but only 39 patients were included for final analysis because of incomplete data collection
Participant milestones
| Measure |
Control
Control: no ketorolac
|
Ketorolac
Ketorolac: Oral Ketorolac
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Baseline characteristics by cohort
| Measure |
Control
n=19 Participants
Control: no ketorolac
|
Ketorolac
n=20 Participants
Ketorolac: Oral Ketorolac
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 Years
STANDARD_DEVIATION 12.9 • n=39 Participants
|
55.7 Years
STANDARD_DEVIATION 8.2 • n=41 Participants
|
55.7 Years
STANDARD_DEVIATION 10.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
BMI
|
29.2 kg/m^2
STANDARD_DEVIATION 6.1 • n=39 Participants
|
32.9 kg/m^2
STANDARD_DEVIATION 6.5 • n=41 Participants
|
31 kg/m^2
STANDARD_DEVIATION 6.3 • n=35 Participants
|
|
Smoker
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: participants were assessed at one single time point up to 8 weeks.The Visual Analog Scale ranges from a minimum score of 0 to a maximum score of 100. A smaller score would be considered a better outcome.
Outcome measures
| Measure |
Control
n=19 Participants
No ketorolac
|
Ketorolac
n=20 Participants
Ketorolac: Oral Ketorolac
|
|---|---|---|
|
Postoperative Visual Analog Scale Scores
|
30 score/units on a scale
Interval 15.0 to 50.0
|
20 score/units on a scale
Interval 8.75 to 32.5
|
SECONDARY outcome
Timeframe: 6 monthsAssessing retear of rotator cuff repair on postop MRI.
Outcome measures
| Measure |
Control
n=11 Participants
No ketorolac
|
Ketorolac
n=11 Participants
Ketorolac: Oral Ketorolac
|
|---|---|---|
|
Number of Participants With Retear of Rotator Cuff Repair
|
3 Participants
|
2 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Ketorolac
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=19 participants at risk
No ketorolac
|
Ketorolac
n=20 participants at risk
Ketorolac: Oral Ketorolac
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting
|
10.5%
2/19 • Number of events 2 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
10.0%
2/20 • Number of events 2 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/19 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
5.0%
1/20 • Number of events 1 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
0.00%
0/20 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Gastrointestinal disorders
Constipation
|
15.8%
3/19 • Number of events 3 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
0.00%
0/20 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
5.0%
1/20 • Number of events 1 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • Number of events 3 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
0.00%
0/20 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Nervous system disorders
Drowsiness
|
21.1%
4/19 • Number of events 4 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
5.0%
1/20 • Number of events 1 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Nervous system disorders
Insomnia
|
5.3%
1/19 • Number of events 1 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
10.0%
2/20 • Number of events 2 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
10.0%
2/20 • Number of events 2 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • Number of events 1 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
0.00%
0/20 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
|
Immune system disorders
Itching
|
5.3%
1/19 • Number of events 1 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
0.00%
0/20 • 14 months
The time frame that is expressed is that over which each participant was assessed
|
Additional Information
John Strony, MD
University Hospitals Cleveland Medical Center
Phone: 908-268-3663
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place