title: The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety.
abstract: OBJECTIVE
  The literature and clinical data support the use of intravenous (IV) infusions of ibuprofen to control pain and reduce the opioid requirements associated with surgical pain. According to current guidelines, IV ibuprofen can be administered via a slow IV infusion performed during a 30-minute period. Although recent studies indicate that more rapid infusions may yield additional benefits for patients, the safety of such an approach needs further evaluation. The main purpose of this study was to determine the safety of single and multiple doses of IV ibuprofen (800 mg) administered over 5 to 10 minutes at the induction of anesthesia and after the surgical procedure for the treatment of postoperative pain.
  
  
  METHODS
  This was a Phase IV, multicenter, open-label, clinical surveillance study. It was conducted at 21 hospitals in the United States, and 300 adult hospitalized patients undergoing surgery were enrolled. The exclusion criteria for the study were: inadequate IV access; hypersensitivity to any component of IV ibuprofen, aspirin, or related products; and any active, clinically significant bleeding. Also excluded were patients who had taken NSAIDs <6 hours before administration of IV ibuprofen; pregnant or breastfeeding female patients; and patients in the perioperative period of coronary artery bypass graft surgery. Patients received 800 mg of IV ibuprofen administered over 5 to 10 minutes preoperatively. Vital signs, adverse events, and pain scores were assessed.
  
  
  RESULTS
  Approximately 22% (65 of 300) of patients reported adverse events (serious and nonserious). The most common adverse event was infusion site pain (34 of 300 [11%]). No deaths were reported. Nine subjects reported serious adverse events, 8 of which occurred during the first 6 hours. All serious events reported were judged unrelated to ibuprofen. Of the 300 total patients, 2 (0.67%) discontinued the study drug due to an adverse event (1 patient discontinued the study because of infusion site pain, and 1 patient withdrew due to a hypersensitivity reaction after drug administration).
  
  
  CONCLUSIONS
  Our study found that IV ibuprofen infused over 5 to 10 minutes at induction of anesthesia is a safe administration option for surgical patients. ClinicalTrials.gov identifier: NCT01334957.
authors.affiliation: Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Tong J
authors.initials: TJ
authors.lastname: Gan
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: Cleveland Clinic, Anesthesiology and Outcomes Research, Cleveland, Ohio.
authors.forename: Alparslan
authors.initials: A
authors.lastname: Turan
authors.affiliation: Rush University Medical Center, Anesthesiology and Pain Medicine, Chicago, Illinois.
authors.forename: Asokumar
authors.initials: A
authors.lastname: Buvanendran
authors.affiliation: Department of Anesthesiology, Perioperative and Pain Management, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.
authors.forename: Beverly K
authors.initials: BK
authors.lastname: Philip
authors.affiliation: Thomas Jefferson University, Anesthesiology and Pain Management, Philadelphia, Pennsylvania.
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Viscusi
authors.affiliation: Department of Anesthesiology, Wexner Medical Center, The Ohio State University, Columbus, Ohio.
authors.forename: Suren
authors.initials: S
authors.lastname: Soghomonyan
authors.affiliation: Department of Anesthesiology, Wexner Medical Center, The Ohio State University, Columbus, Ohio; Department of Neurological Surgery, Wexner Medical Center, The Ohio State University, Columbus, Ohio. Electronic address: sergio.bergese@osumc.edu.
authors.forename: Sergio D
authors.initials: SD
authors.lastname: Bergese
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005414:Flatulence / Q000139:chemically induced; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects*; D007262:Infusions, Intravenous / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D013997:Time Factors; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen
keywords: NSAIDs; ibuprofen; intravenous analgesics; nonopioid analgesics; perioperative pain management; surgical pain