Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Completed · Phase 4

Conditions studied: Pain, Fever

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 treatment of fever or pain in the hospital setting.

Key facts

Study ID

NCT01334944

Run by

Cumberland Pharmaceuticals

People needed

150

Starts

2011-06-01

Expected to finish

2012-10-01

Last updated by the study team

2023-07-05

Who can join

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

You may qualify if…

• Pain: Patients with baseline Visual Analog Scale assessment >3, -and/or- Fever: Patients with temperature >101°F.

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

• UCSD — San Diego, California, United States
• Danbury — Danbury, Connecticut, United States
• University of Miami - Miller School of Medicine — Miami, Florida, United States
• Grady — Atlanta, Georgia, United States
• Beth Israel Deaconnes MC — Boston, Massachusetts, United States
• Columbia — New York, New York, United States
• The University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Fairview — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Lankenau — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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