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

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.

Intravenous ibuprofen for postoperative pain.

SUMMARY A multimodal analgesic approach involving intravenous NSAIDs in the perioperative setting has been common practice for many years outside of the USA. As an adjunct to the central analgesic effects of opioids, intravenous NSAIDs may be important for perioperative pain management due to their analgesic and peripheral anti-inflammatory effects. Together, these agents may attenuate the pain resulting from the surgical procedure better than either agent used singly. Prior to 2009, ketorolac was the only intravenous NSAID approved in the USA for the treatment of pain. However, in June 2009, intravenous ibuprofen (Caldolor(®)) was approved by the US FDA for the treatment of mild-to-moderate pain as a single agent and moderate-to-severe pain as an adjunct to opioids. A growing body of research has demonstrated the efficacy and safety of intravenous ibuprofen in the perioperative setting and is reviewed herein.