Disclosure: This study was supported by Cumberland Pharmaceuticals, Inc. Amy Rock, PhD and Leo Pavliv, RPh are employed by Cumberland Pharmaceuticals, Inc.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen (IV-Ibuprofen) in the Management of Postoperative Pain Following Abdominal Hysterectomy
Version of Record online: 19 JUL 2010
© 2010 The Authors. Pain Practice © 2010 World Institute of Pain
Volume 11, Issue 1, pages 23–32, January/February 2011
How to Cite
Kroll, P. B., Meadows, L., Rock, A. and Pavliv, L. (2011), A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen (IV-Ibuprofen) in the Management of Postoperative Pain Following Abdominal Hysterectomy. Pain Practice, 11: 23–32. doi: 10.1111/j.1533-2500.2010.00402.x
- Issue online: 11 JAN 2011
- Version of Record online: 19 JUL 2010
- Submitted: February 23, 2010; Revision accepted: April 29, 2010
- postoperative pain;
- nonsteroidal anti-inflammatory drugs;
- intravenous ibuprofen;
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.