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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01334957
First received: April 12, 2011
Last updated: May 20, 2014
Last verified: May 2014

April 12, 2011
May 20, 2014
June 2011
December 2012   (final data collection date for primary outcome measure)
  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
  • To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
To determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01334957 on ClinicalTrials.gov Archive Site
  • To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
  • To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
  • To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Not Provided
Not Provided
 
Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen

The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Intravenous ibuprofen
800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Other Name: Caldolor
Experimental: Intravenous ibuprofen
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.
Intervention: Drug: Intravenous ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
January 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for surgery with anticipated need for postoperative analgesia

Exclusion Criteria:

  1. Patients with inadequate IV access
  2. Patients <18 years of age
  3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
  4. Active hemorrhage or clinically significant bleeding
  5. Pregnant or nursing
  6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
  7. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions
  8. Refusal to provide written authorization for use and disclosure of protected health information
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01334957
CPI-CL-016
Yes
Cumberland Pharmaceuticals
Cumberland Pharmaceuticals
Not Provided
Study Director: Art P Wheeler, M.D. Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP