A Multicenter, Open-label, Surveillance Trail To Evaluate The Safety And Efficacy Of A Shortened Infusion Time Of Intravenous Ibuprofen
Sergio D. Bergese, MD; Keith Candiotti, MD; Sabry S. Ayad, MD; Suren Soghomonyan, MD, Phd; Tong J. Gan, MD
This was a Phase IV multicenter, open-label, surveillance clinical study. Thirteen clinical centers enrolled a total of 150 adult hospitalized patients with pain or fever. Patients experiencing pain received 800 mg intravenous ibuprofen infused over 5 – 10 minutes every 6 hours for up to 24 hours (4 doses) and patients experiencing fever received 400 mg intravenous ibuprofen infused over 5 – 10 minutes every 4 hours for up to 24 hours (6 doses). The main purpose of the study was to determine the safety profile and efficacy of intravenous ibuprofen administered over 5 – 10 minutes for the treatment of pain or fever in hospitalized patients. Vital signs, adverse events, and pain scores were assessed.
The authors concluded that a 5 – 10 minute infusion of IV Ibuprofen was well tolerated and supports intravenous ibuprofen as a treatment for pain and fever in hospitalized patients.
CALDOLOR must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis. CALDOLOR should not be given as an IV bolus or IM injection.1