TY - JOUR
T1 - The shortened infusion time of intravenous ibuprofen part 1
T2 - A multicenter, open-label, surveillance trial to evaluate safety and efficacy
AU - Bergese, Sergio D.
AU - Candiotti, Keith
AU - Ayad, Sabry S.
AU - Soghomonyan, Suren
AU - Gan, Tong J.
N1 - Funding Information:
Drs. Bergese, Candiotti, Ayad, and Gan received research grants from Cumberland Pharmaceuticals, Inc. specifically to support this trial. The authors of the manuscript designed the study, collected the data, performed data analysis and interpretation, wrote the manuscript and made the decision to submit it for publication. The study sponsors did not participate in any of the aforementioned steps. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
PY - 2015/2/1
Y1 - 2015/2/1
N2 - Purpose The main purpose of the study was to determine the safety profile and efficacy of intravenous ibuprofen administered over 5 to 10 minutes for the treatment of pain or fever in hospitalized patients. Current evidence supports the use of intravenous infusions of ibuprofen to control pain and reduce the opioid requirements associated with surgical pain. Current dosing guidelines recommend that the drug be administered over 30 minutes. However, a more rapid infusion might yield additional benefits. The safety profile and efficacy of a shortened infusion time requires additional study. Methods This was a Phase IV multicenter, open-label, surveillance clinical study. Thirteen clinical centers located in the United States enrolled a total of 150 adult hospitalized patients with pain or fever. Patients experiencing pain received 800 mg intravenous ibuprofen infused over 5 to 10 minutes every 6 hours for up to 24 hours (4 doses) and patients experiencing fever received 400 mg intravenous ibuprofen infused over 5 to 10 minutes every 4 hours for up to 24 hours (6 doses). Vital signs, adverse events, and pain scores were assessed. The exclusion criteria included inadequate intravenous access; patients younger than 18 years of age; history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin, or other nonsteroid anti-inflammatory drugs; active hemorrhage or clinically significant bleeding; pregnancy or nursing; and patients in the perioperative period in the setting of coronary artery bypass graft surgery. Findings Adverse events were reported for 43 of 150 patients (29%). The most common adverse events experienced by patients were infusion site pain in 22 of 150 patients (15%) and flatulence (8 of 150 [5%]). Four patients (3%) discontinued the study drug due to infusion-site pain. In the patients experiencing fever, temperature decreased from baseline over 4 hours (mean [SD] reduction of 1.5 [1.25]°F). In patients experiencing pain, patient-reported visual analog scale scores decreased from baseline over 4 hours (mean [SD] reduction of 27.1 [31.29] mm). Implications The study demonstrates that more rapid administration of intravenous ibuprofen is well tolerated and supports intravenous ibuprofen as an effective treatment for pain and fever in hospitalized patients.
AB - Purpose The main purpose of the study was to determine the safety profile and efficacy of intravenous ibuprofen administered over 5 to 10 minutes for the treatment of pain or fever in hospitalized patients. Current evidence supports the use of intravenous infusions of ibuprofen to control pain and reduce the opioid requirements associated with surgical pain. Current dosing guidelines recommend that the drug be administered over 30 minutes. However, a more rapid infusion might yield additional benefits. The safety profile and efficacy of a shortened infusion time requires additional study. Methods This was a Phase IV multicenter, open-label, surveillance clinical study. Thirteen clinical centers located in the United States enrolled a total of 150 adult hospitalized patients with pain or fever. Patients experiencing pain received 800 mg intravenous ibuprofen infused over 5 to 10 minutes every 6 hours for up to 24 hours (4 doses) and patients experiencing fever received 400 mg intravenous ibuprofen infused over 5 to 10 minutes every 4 hours for up to 24 hours (6 doses). Vital signs, adverse events, and pain scores were assessed. The exclusion criteria included inadequate intravenous access; patients younger than 18 years of age; history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin, or other nonsteroid anti-inflammatory drugs; active hemorrhage or clinically significant bleeding; pregnancy or nursing; and patients in the perioperative period in the setting of coronary artery bypass graft surgery. Findings Adverse events were reported for 43 of 150 patients (29%). The most common adverse events experienced by patients were infusion site pain in 22 of 150 patients (15%) and flatulence (8 of 150 [5%]). Four patients (3%) discontinued the study drug due to infusion-site pain. In the patients experiencing fever, temperature decreased from baseline over 4 hours (mean [SD] reduction of 1.5 [1.25]°F). In patients experiencing pain, patient-reported visual analog scale scores decreased from baseline over 4 hours (mean [SD] reduction of 27.1 [31.29] mm). Implications The study demonstrates that more rapid administration of intravenous ibuprofen is well tolerated and supports intravenous ibuprofen as an effective treatment for pain and fever in hospitalized patients.
KW - fever
KW - ibuprofen
KW - intravenous analgesics
KW - nonopioid analgesics
KW - nonsterioidal antiinflammatory drugs
KW - pain
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U2 - 10.1016/j.clinthera.2014.12.004
DO - 10.1016/j.clinthera.2014.12.004
M3 - Article
C2 - 25577542
AN - SCOPUS:84923644621
VL - 37
SP - 360
EP - 367
JO - Clinical Therapeutics
JF - Clinical Therapeutics
SN - 0149-2918
IS - 2
ER -