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.


CONCLUSIONS
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.
Kroll
Peter B
PB
Comprehensive Pain Specialists, Hendersonville, Tennessee 37075, USA. krolls2k@comcast.net
Meadows
Laura
L
Rock
Amy
A
Pavliv
Leo
L
D000005:Abdomen / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D019540:Area Under Curve; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects*; D007052:Ibuprofen / Q000008:administration & dosage*; D007275:Injections, Intravenous; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology*; D013997:Time Factors; D055815:Young Adult
D018712:Analgesics, Non-Narcotic; D007052:Ibuprofen