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Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

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ClinicalTrials.gov Identifier: NCT01334957
Recruitment Status : Completed
First Posted : April 13, 2011
Results First Posted : June 23, 2014
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Intravenous ibuprofen
Enrollment 300
Recruitment Details Adult hospitalized patients undergoing surgery
Pre-assignment Details

Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study.

Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS.

Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Period Title: Overall Study
Started 300
Received Single Dose 252
Received Multiple Doses 48
Completed 300
Not Completed 0
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Overall Number of Baseline Participants 300
Hide Baseline Analysis Population Description
Formal sample size calculations were not performed. The intent is to enroll 300 patients to provide descriptive safety and efficacy data.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Years
Greater than or equal to 18 years of age Number Analyzed 300 participants
300
[1]
Measure Description: Greater than or equal to 18 years of age
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
Female
189
  63.0%
Male
111
  37.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
Hispanic or Latino
29
   9.7%
Not Hispanic or Latino
271
  90.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
American Indian or Alaska Native
1
   0.3%
Asian
5
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
60
  20.0%
White
229
  76.3%
More than one race
0
   0.0%
Unknown or Not Reported
5
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 300 participants
300
1.Primary Outcome
Title To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
Hide Description The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description:

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Overall Number of Participants Analyzed 252
Measure Type: Number
Unit of Measure: Number of Serious Adverse Events
8
2.Primary Outcome
Title To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Hide Description The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description:

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Overall Number of Participants Analyzed 252
Measure Type: Number
Unit of Measure: Number of Adverse Events
49
3.Secondary Outcome
Title To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.
Hide Description The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description:

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Number of Serious Adverse Events
0
4.Secondary Outcome
Title To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Hide Description The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description:

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Number of Adverse Events
16
5.Secondary Outcome
Title To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.
Hide Description Visual Analog Scale (VAS) assessments 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 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description:

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Overall Number of Participants Analyzed 228
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
30.9
(27.5 to 34.2)
Time Frame During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Ibuprofen
Hide Arm/Group Description

Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.

Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

All-Cause Mortality
Intravenous Ibuprofen
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Ibuprofen
Affected / at Risk (%) # Events
Total   8/300 (2.67%)    
Gastrointestinal disorders   
Abdominal Compartment Syndrome * 1  1/300 (0.33%)  1
Peritoneal Adhesions * 1  1/300 (0.33%)  1
Hepatobiliary disorders   
Bile Duct Stone * 1  1/300 (0.33%)  1
Injury, poisoning and procedural complications   
Airway Complication Of Anaesthesia * 1  1/300 (0.33%)  1
Investigations   
Oxygen Saturation Decreased * 1  1/300 (0.33%)  1
Renal and urinary disorders   
Urinary Retention * 1  1/300 (0.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  1/300 (0.33%)  1
Vascular disorders   
Hypertension * 1  1/300 (0.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Intravenous Ibuprofen
Affected / at Risk (%) # Events
Total   49/300 (16.33%)    
Cardiac disorders   
Bradycardia * 1  8/300 (2.67%)  9
Gastrointestinal disorders   
Nausea * 1  10/300 (3.33%)  10
Flatulence * 1  9/300 (3.00%)  9
General disorders   
Infusion Site Pain * 1  34/300 (11.33%)  34
Injury, poisoning and procedural complications   
Anaemia Postoperative * 1  10/300 (3.33%)  10
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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: Dr. Amy Rock
Organization: Cumberland Pharmaceuticals Inc.
Phone: 615-255-0068
EMail: arock@cumberlandpharma.com
Layout table for additonal information
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01334957     History of Changes
Other Study ID Numbers: CPI-CL-016
First Submitted: April 12, 2011
First Posted: April 13, 2011
Results First Submitted: April 15, 2014
Results First Posted: June 23, 2014
Last Update Posted: May 18, 2016