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Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225732
First Posted: September 26, 2005
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
Results First Submitted: April 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Other: Normal saline as placebo comparator
Drug: Intravenous ibuprofen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the medical practices and/or clinics of the investigator/sub-investigators.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 319 participants were randomized into two treatment groups. Randomized participants were additionally stratified by age and weight; three participants were randomized to incorrect stratification categories. All 319 participants received at least one dose of clinical trial material.

Reporting Groups
  Description
Placebo The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
800 mg Intravenous Ibuprofen The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.

Participant Flow:   Overall Study
    Placebo   800 mg Intravenous Ibuprofen
STARTED   153   166 
COMPLETED   153   166 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
800 mg Intravenous Ibuprofen The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
Total Total of all reporting groups

Baseline Measures
   Placebo   800 mg Intravenous Ibuprofen   Total 
Overall Participants Analyzed 
[Units: Participants]
 153   166   319 
Age, Customized 
[Units: Participants]
     
Less than or equal to 45 years   104   110   214 
45 to 70 years of age   49   56   105 
Gender 
[Units: Participants]
     
Female   153   166   319 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   52   71   123 
Black or African American   91   84   175 
Hispanic   8   11   19 
Asian   0   0   0 
Other   2   0   2 
Region of Enrollment 
[Units: Participants]
     
United States   153   166   319 
Weight 
[Units: Kilograms]
     
Less than or equal to 75 kilograms   57   61   118 
Greater than 75 kilograms   96   105   201 


  Outcome Measures

1.  Primary:   Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery   [ Time Frame: 24 Hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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, Ph.D.
Organization: Cumberland Pharmaceuticals Inc.
phone: 615-255-0068
e-mail: arock@cumberlandpharma.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00225732     History of Changes
Other Study ID Numbers: CPI-CL-008
First Submitted: September 22, 2005
First Posted: September 26, 2005
Results First Submitted: April 1, 2011
Results First Posted: September 15, 2011
Last Update Posted: June 22, 2016