Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
- Registration Number
- NCT01334957
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Patients scheduled for surgery with anticipated need for postoperative analgesia
- Patients with inadequate IV access
- Patients <18 years of age
- History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
- Active hemorrhage or clinically significant bleeding
- Pregnant or nursing
- Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
- 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
- Refusal to provide written authorization for use and disclosure of protected health information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravenous ibuprofen 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.
- Primary Outcome Measures
Name Time Method To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. 6 hours 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. 6 hours The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen
- Secondary Outcome Measures
Name Time Method To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain. 6 hours 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. 6 hours 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.
Trial Locations
- Locations (22)
RUSH Univ. Medical Center
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
UC San Diego Regional Center
🇺🇸La Jolla, California, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
Duke University Health System
🇺🇸Durham, North Carolina, United States
North Mississippi Sports Medicine & Orthopaedic Clinic
🇺🇸Tupelo, Mississippi, United States
University of Miami Health System
🇺🇸Miami, Florida, United States
Sheridan Clinical Research
🇺🇸Plantation, Florida, United States
Neurovations (Queen of the Valley Hospital)
🇺🇸Napa, California, United States
Univ. of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Albany Medical Center
🇺🇸Albany, New York, United States
North Shore - Long Island Jewish Health System
🇺🇸Manhasset, New York, United States
State of New York Downstate Medical Center (SUNY)
🇺🇸Brooklyn, New York, United States
Penn State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Hendersonville Hospital/Comprehensive Pain Specialists
🇺🇸Hendersonville, Tennessee, United States
Parkland Memorial
🇺🇸Dallas, Texas, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States