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Dose Response of Ketorolac in Knee Arthroscopy

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ClinicalTrials.gov Identifier: NCT02181426
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : June 8, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Meniscectomy
Intervention Drug: Ketorolac Dose
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0 mg of Ketorolac 7.5 mg of Ketorolac 15 mg Ketorolac 30 mg Ketorolac
Hide Arm/Group Description

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).

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).

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).

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).

Period Title: Overall Study
Started 28 28 28 28
Completed 28 28 28 28
Not Completed 0 0 0 0
Arm/Group Title 0 mg of Ketorolac 7.5 mg of Ketorolac 15 mg Ketorolac 30 mg Ketorolac Total
Hide Arm/Group Description

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).

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).

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).

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 of all reporting groups
Overall Number of Baseline Participants 28 28 28 28 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 28 participants 28 participants 112 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
28
 100.0%
28
 100.0%
28
 100.0%
112
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 28 participants 28 participants 112 participants
49.4  (11.9) 44.2  (12.7) 44.7  (14.2) 44.4  (13) 45.7  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 28 participants 28 participants 112 participants
Female
14
  50.0%
8
  28.6%
15
  53.6%
12
  42.9%
49
  43.8%
Male
14
  50.0%
20
  71.4%
13
  46.4%
16
  57.1%
63
  56.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 28 participants 28 participants 112 participants
28
 100.0%
28
 100.0%
28
 100.0%
28
 100.0%
112
 100.0%
1.Primary Outcome
Title PACU Opiate Consumption
Hide Description Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Time Frame Less than 1 day (PACU stay in the postoperative period)
Hide Outcome Measure Data
Hide Analysis Population Description
The study enrolled 112 patient with 28 patients randomized to each group.
Arm/Group Title 0 mg of Ketorolac 7.5 mg of Ketorolac 15 mg Ketorolac 30 mg Ketorolac
Hide Arm/Group Description:

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).

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).

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).

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 Number of Participants Analyzed 28 28 28 28
Mean (Standard Error)
Unit of Measure: IV Morphine Equivalents (mg)
7.7  (0.86) 6.3  (0.86) 6.5  (0.86) 5.0  (0.86)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0 mg of Ketorolac 7.5 mg of Ketorolac 15 mg Ketorolac 30 mg Ketorolac
Hide Arm/Group Description

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).

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).

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).

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).

All-Cause Mortality
0 mg of Ketorolac 7.5 mg of Ketorolac 15 mg Ketorolac 30 mg Ketorolac
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0 mg of Ketorolac 7.5 mg of Ketorolac 15 mg Ketorolac 30 mg Ketorolac
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0 mg of Ketorolac 7.5 mg of Ketorolac 15 mg Ketorolac 30 mg Ketorolac
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: Research Coordinator for Anesthesia and Perioperative Medicine
Organization: Medical University of South Carolina, Department of Anesthesia and Perioperative Medicine
Phone: 843-792-2322
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02181426     History of Changes
Other Study ID Numbers: Ketorolac Knee Arthroscopy
First Submitted: June 26, 2014
First Posted: July 4, 2014
Results First Submitted: January 29, 2018
Results First Posted: June 8, 2018
Last Update Posted: September 21, 2018