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Comparative efficacy of oral ibuprofen arginine and intramuscular ketorolac in patients with postoperative pain

Laveneziana, D.; Riva, A.; Bonazzi, M.; Cipolla, M.; Migliavacca, S.

Clinical Drug Investigation 11(Suppl 1): 8-14

1996


ISSN/ISBN: 1173-2563
DOI: 10.2165/00044011-199600111-00004
Accession: 008349596

The comparative clinical efficacy and tolerability of ibuprofen arginine and ketorolac were determined in a study that used a double-blind double-dummy protocol. 124 patients who underwent surgical repair of inguinal hernia at a single medical centre were randomly assigned to receive either oral ibuprofen arginine 400 mg, ketorolac 30 mg by intramuscular injection or placebo. Pain intensity was assessed at baseline and at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes after medication administration, on a Visual Analogue Scale (VAS) ranging from no pain (0 mm) to unbearable pain (100 mm). 59 patients rated baseline pain between 61 and 80 mm on the VAS and 65 patients rated baseline pain between 81 and 100 mm on the VAS. Pain intensity was reduced in all 3 treatment groups after administration of study medication, with the most marked response occurring within the first hour. In patients who rated baseline pain between 61 and 80 mm on the VAS, mean VAS scores were reduced significantly in both active treatment groups compared with placebo (p lt 0.05); mean VAS scores decreased to 29, 27 and 47 mm in the ibuprofen arginine, ketorolac and placebo groups, respectively, 120 minutes after treatment administration. However, no significant differences were observed between the active treatment groups. In patients who rated baseline pain between 81 and 100 mm, no statistically significant differences were found between the treatment groups (p gt 0.05). Specifically, mean VAS scores decreased to 50, 38 and 44 mm in the ibuprofen arginine, ketorolac and placebo groups, respectively, 120 minutes after medication administration. No significant differences were observed between treatment groups with regard to the number of patients requesting rescue medication, the time interval before the request, or pain intensity at the time of request. 43% of ibuprofen arginine recipients, 55% of ketorolac recipients and 33% of placebo recipients rated their medication as good or better (p gt 0.05). No adverse events were observed throughout the study. In conclusion, oral ibuprofen arginine exhibits similar efficacy to intramuscular ketorolac in the treatment of pain after surgical repair of inguinal hernia. Therefore, oral ibuprofen arginine may prove to be a useful option in the treatment of patients with moderately severe postsurgical pain.

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