Trial Outcomes & Findings for Dose Response of Ketorolac in Knee Arthroscopy (NCT NCT02181426)
NCT ID: NCT02181426
Last Updated: 2018-09-21
Results Overview
Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Less than 1 day (PACU stay in the postoperative period)
Results posted on
2018-09-21
Participant Flow
Participant milestones
| Measure |
0 mg of Ketorolac
participant receives 0 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
7.5 mg of Ketorolac
participant receives 7.5 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
15 mg Ketorolac
participant receives 15 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
30 mg Ketorolac
participant receives 30mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Response of Ketorolac in Knee Arthroscopy
Baseline characteristics by cohort
| Measure |
0 mg of Ketorolac
n=28 Participants
participant receives 0 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
7.5 mg of Ketorolac
n=28 Participants
participant receives 7.5 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
15 mg Ketorolac
n=28 Participants
participant receives 15 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
30 mg Ketorolac
n=28 Participants
participant receives 30mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
Total
n=112 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
49.4 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
44.7 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
44.4 Years
STANDARD_DEVIATION 13 • n=4 Participants
|
45.7 Years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Less than 1 day (PACU stay in the postoperative period)Population: The study enrolled 112 patient with 28 patients randomized to each group.
Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Outcome measures
| Measure |
0 mg of Ketorolac
n=28 Participants
participant receives 0 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
7.5 mg of Ketorolac
n=28 Participants
participant receives 7.5 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
15 mg Ketorolac
n=28 Participants
participant receives 15 mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
30 mg Ketorolac
n=28 Participants
participant receives 30mg of Ketorolac
Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
|
|---|---|---|---|---|
|
PACU Opiate Consumption
|
7.7 IV Morphine Equivalents (mg)
Standard Error 0.86
|
6.3 IV Morphine Equivalents (mg)
Standard Error 0.86
|
6.5 IV Morphine Equivalents (mg)
Standard Error 0.86
|
5.0 IV Morphine Equivalents (mg)
Standard Error 0.86
|
Adverse Events
0 mg of Ketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
7.5 mg of Ketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
15 mg Ketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 mg 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
Research Coordinator for Anesthesia and Perioperative Medicine
Medical University of South Carolina, Department of Anesthesia and Perioperative Medicine
Phone: 843-792-2322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place