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A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery

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ClinicalTrials.gov Identifier: NCT01650519
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : July 10, 2014
Last Update Posted : June 23, 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 Arthroscopic Knee Surgery
Interventions Drug: IV ibuprofen
Drug: IV ketorolac
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Period Title: Overall Study
Started 20 31
Completed 19 31
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title IV Ibuprofen IV Ketorolac Total
Hide Arm/Group Description

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Total of all reporting groups
Overall Number of Baseline Participants 20 31 51
Hide Baseline Analysis Population Description
The Intent-to-treat population consists of all patients who received at least a partial dose of study medication.
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Subject greater than or equal to 18 years of age Number Analyzed 20 participants 31 participants 51 participants
43  (12.6) 45  (13) 44  (12.8)
[1]
Measure Description: Subject greater than or equal to 18 years of age
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 31 participants 51 participants
Female
6
  30.0%
10
  32.3%
16
  31.4%
Male
14
  70.0%
21
  67.7%
35
  68.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 31 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  15.0%
1
   3.2%
4
   7.8%
White
17
  85.0%
29
  93.5%
46
  90.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.2%
1
   2.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 31 participants 51 participants
Hispanic or Latino
0
   0.0%
1
   3.2%
1
   2.0%
Not Hispanic or Latino
20
 100.0%
30
  96.8%
50
  98.0%
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 20 participants 31 participants 51 participants
20 31 51
1.Primary Outcome
Title Efficacy of IV Ibuprofen for Post-op Pain.
Hide Description Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. 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 o and 100.
Time Frame first possible assessment following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description:

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Overall Number of Participants Analyzed 19 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
VAS at Rest (mm) 8  (6.6) 34  (25.0)
VAS with Movement (mm) 19  (17.4) 41  (25.8)
2.Secondary Outcome
Title Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge
Hide Description Measurement of the amount of rescue medication in the postoperative period.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description:

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Overall Number of Participants Analyzed 19 31
Mean (Standard Deviation)
Unit of Measure: milligrams
Narcotic 5.4  (6.02) 20.4  (15.87)
Acetaminophen 162.5  (229.81) 325  (269.90)
3.Secondary Outcome
Title Time to Discharge.
Hide Description Measurement of the time to discharge in the postoperative period.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description:

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Overall Number of Participants Analyzed 19 31
Mean (Standard Deviation)
Unit of Measure: Hours
1.8  (0.12) 1.8  (0.08)
4.Secondary Outcome
Title Patient Satisfaction.
Hide Description

Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome.

Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).

Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description:

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Emotions 20.2  (2.35) 20.7  (2.25)
Physical Comfort 28.3  (4.39) 26.9  (2.98)
Patient Support 30.5  (1.20) 29.0  (3.93)
Physical Independence 22.2  (2.55) 21.3  (3.32)
Pain 9.5  (3.45) 10.9  (3.34)
5.Secondary Outcome
Title Incidence of Serious Adverse Events (SAEs).
Hide Description Measurement of the incidence of serious adverse events.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description:

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Overall Number of Participants Analyzed 20 31
Measure Type: Number
Unit of Measure: Number of Events
0 0
6.Secondary Outcome
Title Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours
Hide Description Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject 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 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site.
Time Frame 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description:

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Overall Number of Participants Analyzed 10 13
Mean (Standard Error)
Unit of Measure: units on a scale
VAS at Rest (mm) 4  (3.7) 13  (10.8)
VAS with Movement (mm) 12  (12.2) 23  (16.5)
7.Secondary Outcome
Title Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge
Hide Description Measurement of the amount of time to rescue medication in the postoperative period.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description:

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

Overall Number of Participants Analyzed 20 31
Mean (Standard Deviation)
Unit of Measure: Hours
1.7  (0.19) 1  (0.11)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Ibuprofen IV Ketorolac
Hide Arm/Group Description

800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.

IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.

Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.

IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds

All-Cause Mortality
IV Ibuprofen IV Ketorolac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Ibuprofen IV Ketorolac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/31 (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 IV Ketorolac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/31 (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
Layout table for Results Point of Contact information
Name/Title: Amy Rock, PhD
Organization: Cumberland Pharmaceutical Inc.
Phone: 615-255-0068
EMail: arock@cumberlandpharma.com
Layout table for additonal information
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01650519     History of Changes
Other Study ID Numbers: CPI-CL-017
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: April 15, 2014
Results First Posted: July 10, 2014
Last Update Posted: June 23, 2016