A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen (IV-Ibuprofen) in the Management of Postoperative Pain Following Abdominal Hysterectomy.
Author(s): Kroll PB, Meadows L, Rock A, Pavliv L
Affiliation(s): Comprehensive Pain Specialists, Hendersonville, Tennessee.
Publication date & source: 2010-07-19, Pain Pract., [Epub ahead of print]
Abstract Background: Ibuprofen and other nonsteroidal anti-inflammatory drugs are widely used to block pain and inflammation in a variety of settings. Contrarily, opioid analgesia does not block the inflammatory component of pain and the use of these agents can be accompanied by serious side effects. We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of intravenous ibuprofen (IV-ibuprofen) as a postoperative analgesic. Methods: A total of 319 patients were randomly assigned in a 1:1 ratio to receive 800 IV-ibuprofen or placebo every 6 hours; in addition patients had access to morphine at a dose of 1-2 mg every 5 minutes. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. Results: During the first 24 hours of treatment, the median morphine requirement was reduced by 19% (P </= 0.001) and resulted in a significant reduction in pain at rest (AUC, 6 to 24 hours and 12 to 24 hours, P < 0.001) and pain with movement (AUC, 6 to 24 hours, P = 0.010 and 12 to 24 hours, P </= 0.001) as measured by the visual analog scale (VAS) in patients receiving 800 mg IV-ibuprofen compared to placebo. Time to ambulation was significantly faster (P = 0.018) in the IV-ibuprofen treated group, as well. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events. Conclusion: This study demonstrated that IV-ibuprofen is an effective analgesic medication that is safe and well tolerated when administered as an 800 mg dose every 6 hours in patients undergoing total abdominal hysterectomy surgery.
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