A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy

Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.


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 (i.v.-ibuprofen) as a postoperative analgesic.

Methods: A total of 319 patients were randomly assigned in a 1:1 ratio to receive 800 i.v.-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 i.v.-ibuprofen compared to placebo. Time to ambulation was significantly faster (P = 0.018) in the i.v.-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 i.v.-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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdomen / surgery
  • Adolescent
  • Adult
  • Aged
  • Analgesics, Non-Narcotic / administration & dosage*
  • Area Under Curve
  • Double-Blind Method
  • Female
  • Humans
  • Hysterectomy / adverse effects*
  • Ibuprofen / administration & dosage*
  • Injections, Intravenous
  • Middle Aged
  • Pain Measurement
  • Pain, Postoperative / drug therapy*
  • Pain, Postoperative / etiology*
  • Time Factors
  • Young Adult


  • Analgesics, Non-Narcotic
  • Ibuprofen