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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Intravenous ibuprofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 300
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Intravenous ibuprofen
800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Other Name: Caldolor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334957

Locations
United States, California
UC San Diego Regional Center
La Jolla, California, United States, 92037
Neurovations (Queen of the Valley Hospital)
Napa, California, United States, 94558
United States, Florida
University of Miami Health System
Miami, Florida, United States, 33136
Sheridan Clinical Research
Plantation, Florida, United States, 33324
United States, Illinois
RUSH Univ. Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
Univ. of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121-2483
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
United States, Mississippi
North Mississippi Sports Medicine & Orthopaedic Clinic
Tupelo, Mississippi, United States, 38801
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
State of New York Downstate Medical Center (SUNY)
Brooklyn, New York, United States, 11203
North Shore - Long Island Jewish Health System
Manhasset, New York, United States, 11030
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Health System
Durham, North Carolina, United States, 27710
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University Medical Center
Columbus, Ohio, United States, 43201
United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Hendersonville Hospital/Comprehensive Pain Specialists
Hendersonville, Tennessee, United States, 37075
United States, Texas
Parkland Memorial
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art P Wheeler, M.D. Cumberland Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01334957     History of Changes
Other Study ID Numbers: CPI-CL-016
Study First Received: April 12, 2011
Results First Received: April 15, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014