title: The shortened infusion time of intravenous ibuprofen part 1: a multicenter, open-label, surveillance trial to evaluate safety and efficacy.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio; Department of Neurosurgery, The Ohio State University, Wexner Medical Center, Columbus, Ohio. Electronic address: sergio.bergese@osumc.edu.
authors.forename: Sergio D
authors.initials: SD
authors.lastname: Bergese
authors.affiliation: Department of Anesthesiology, Perioperative Medicine, and Pain Management, University of Miami, Miller School of Medicine, Miami, Florida.
authors.forename: Keith
authors.initials: K
authors.lastname: Candiotti
authors.affiliation: Department of Anesthesiology, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Sabry S
authors.initials: SS
authors.lastname: Ayad
authors.affiliation: Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio.
authors.forename: Suren
authors.initials: S
authors.lastname: Soghomonyan
authors.affiliation: Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Tong J
authors.initials: TJ
authors.lastname: Gan
mesh_terms: D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D001241:Aspirin / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006760:Hospitalization; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous / Q000379:methods; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D001241:Aspirin; D007052:Ibuprofen
keywords: fever; ibuprofen; intravenous analgesics; nonopioid analgesics; nonsterioidal antiinflammatory drugs; pain