A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial of Intravenous Ibuprofen (IV‐Ibuprofen) in the Management of Postoperative Pain Following Abdominal Hysterectomy

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.