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

Completed · Phase 4

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01334957

Run by

Cumberland Pharmaceuticals

People needed

300

Starts

2011-06-01

Expected to finish

2013-01-01

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled for surgery with anticipated need for postoperative analgesia

You may not qualify if…

• 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

Where it is running

• UC San Diego Regional Center — La Jolla, California, United States
• Neurovations (Queen of the Valley Hospital) — Napa, California, United States
• University of Miami Health System — Miami, Florida, United States
• Sheridan Clinical Research — Plantation, Florida, United States
• RUSH Univ. Medical Center — Chicago, Illinois, United States
• Univ. of Kansas Medical Center — Kansas City, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Detroit Medical Center — Detroit, Michigan, United States
• North Mississippi Sports Medicine & Orthopaedic Clinic — Tupelo, Mississippi, United States
• Albany Medical Center — Albany, New York, United States
• State of New York Downstate Medical Center (SUNY) — Brooklyn, New York, United States
• North Shore - Long Island Jewish Health System — Manhasset, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Health System — Durham, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Hendersonville Hospital/Comprehensive Pain Specialists — Hendersonville, Tennessee, United States
• Parkland Memorial — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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