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Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

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ClinicalTrials.gov Identifier: NCT01901393
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : February 15, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: IV ibuprofen
Drug: Ketorolac
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
Period Title: Overall Study
Started 51 49
Completed 50 49
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title IV Ibuprofen Ketorolac Total
Hide Arm/Group Description

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac

 Total of all reporting groups
Overall Number of Baseline Participants 51 49 100
Hide Baseline Analysis Population Description
The Intent-to-Treat population consisted of all subjects who were enrolled and received at least a partial dose of investigational medicinal product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 49 participants 100 participants
45  (13.3) 46  (15.5) 46  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
Female
18
  35.3%
21
  42.9%
39
  39.0%
Male
33
  64.7%
28
  57.1%
61
  61.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
Hispanic or Latino
2
   3.9%
2
   4.1%
4
   4.0%
Not Hispanic or Latino
49
  96.1%
47
  95.9%
96
  96.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.0%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  11.8%
1
   2.0%
7
   7.0%
White
44
  86.3%
48
  98.0%
92
  92.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 49 participants 100 participants
51 49 100
1.Primary Outcome
Title Efficacy of Pain Relief (Pain Intensity at Rest)
Hide Description Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Time Frame First possible time post-surgery, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description:

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
Overall Number of Participants Analyzed 50 49
Mean (Standard Deviation)
Unit of Measure: units on a scale (in mm)
30  (27.0) 32  (25.1)
2.Primary Outcome
Title Efficacy of Pain Relief (Pain Intensity With Movement)
Hide Description Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Time Frame First possible time post-surgery, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description:

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
Overall Number of Participants Analyzed 49 47
Mean (Standard Deviation)
Unit of Measure: units on a scale (in mm)
32  (28.0) 41  (28.2)
3.Secondary Outcome
Title Rescue Medication Use in Post-operative Period
Hide Description Amount of rescue medication (in milligrams) will be measured
Time Frame Post-operative period until discharge, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description:

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
Overall Number of Participants Analyzed 51 49
Mean (Standard Deviation)
Unit of Measure: milligrams
Narcotic 13.7  (17.19) 13.2  (16.50)
Acetaminophen 188.5  (255.06) 179.1  (248.77)
4.Secondary Outcome
Title Time to First Use of Rescue Med Will be Measured
Hide Description Time to first rescue medication (in hours) in the postoperative period through discharge.
Time Frame Post-operative period until discharge, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description:

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
Overall Number of Participants Analyzed 51 49
Mean (Standard Error)
Unit of Measure: hours
1.2  (0.11) 1.2  (0.10)
5.Secondary Outcome
Title Patient Satisfaction
Hide Description Measured using 2 question, 4 point scale.
Time Frame Post-operative period until discharge, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description:

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: Participants
Poor 0 1
Fair 4 8
Good 20 18
Excellent 26 22
6.Secondary Outcome
Title Incidence of Serious Adverse Events
Hide Description Number of subjects experiencing treatment-emergent serious adverse events
Time Frame Post-operative period until discharge, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description:

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: Number of events
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Ibuprofen Ketorolac
Hide Arm/Group Description

800mg ibuprofen

IV ibuprofen

30mg ketorolac

Ketorolac
All-Cause Mortality
IV Ibuprofen Ketorolac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Ibuprofen Ketorolac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Ibuprofen Ketorolac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/49 (0.00%) 
[Not Specified]
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: Amy Rock, PhD
Organization: Cumberland Pharmaceutical Inc.
Phone: 615-255-0068
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01901393     History of Changes
Other Study ID Numbers: CPI-CL-020
First Submitted: July 12, 2013
First Posted: July 17, 2013
Results First Submitted: January 18, 2016
Results First Posted: February 15, 2016
Last Update Posted: March 14, 2016