A controlled comparative study of ibuprofen arginate versus conventional ibuprofen in the treatment of postoperative dental pain.
The analgesic efficacy of an arginine salt of ibuprofen was compared to one of the commercially available forms of conventional ibuprofen in a 500-patient clinical trial in postoperative dental pain. Patients were administered a single dose of ibuprofen arginate (200 mg or 400 mg), conventional ibuprofen (200 mg or 400 mg), orplacebo in this double-blind, randomized, parallel-group trial. Results demonstrated that ibuprofen arginate was a safe and effective analgesia that was superior to conventional ibuprofen in both the amount of pain relief achieved and the time to onset of pain relief. Onset of analgesia, assessed as the median amount of time to achieve meaningful pain relief, was reached after 32 and 31 minutes with ibuprofen arginate 200 and 400 mg, respectively, and 64 and 58 minutes with conventional ibuprofen 200 and 400 mg, respectively (p < 0.05). Patients treated with ibuprofen arginate rated its overall effectiveness higher than those patients treated with conventional ibuprofen. Adverse event profiles were similar across all treatment groups.
Mehlisch
Donald R
DR
Scirex Corporation, Austin, Texas, USA.
Ardia
Alfredo
A
Pallotta
Teresa
T
D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001120:Arginine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D013997:Time Factors; D014081:Tooth Extraction / Q000009:adverse effects
D018712:Analgesics, Non-Narcotic; D004338:Drug Combinations; D001120:Arginine; D007052:Ibuprofen; C106674:ibuprofen arginine