Ibuprofen liquigel for oral surgery pain

Background: Ibuprofen liquigel is a solubilized potassium ibuprofen 200-mg gelatin capsule formulation that was approved for over-the-counter use in 1 995, Objective: This study compared the analgesic efficacy and tolerability of i buprofen liquigel 200 mg, ibuprofen liquigel 400 mg, acetaminophen caplets 1000 mg, and placebo in patients experiencing moderate or severe pain after surgical removal of impacted third molars. Methods: This randomized, double-blind, parallel-group, 6-hour study was co nducted in 210 patients experiencing moderate or severe postoperative pain. Ratings of pain intensity and pain relief were recorded every 15 minutes f or the first hour, at 90 and 120 minutes, and then hourly through hour 6. T he onsets of first perceptible relief and meaningful relief were recorded u sing 2 stopwatches. An analysis of variance model was employed to test for significant differences (P less than or equal to 0.05) between treatment gr oups with respect to pain relief, pain intensity difference, total pain rel ief (TOTPAR); and summed pain intensity difference (SPID). Stopwatch measur es were analyzed using the Cox proportional hazards model. Drug tolerabilit y was assessed by monitoring the occurrence of adverse events. Results: During the first 2 hours of the study (TOTPAR 2 and SPID 2), all a ctive treatments were significantly more efficacious than placebo (P < 0.00 1), with ibuprofen liquigel 200 and 400 mg significantly more efficacious t han acetaminophen 1000 mg (P < 0.05 and P < 0.01, respectively). For the en tire duration of the study (TOTPAR 6 and SPID 6), only the 2 doses of ibupr ofen liquigel were significantly more efficacious than placebo (P < 0.001). Ibuprofen liquigel 200 and 400 mg were also significantly more efficacious than acetaminophen 1000 mg on the summary measures TOTPAR 6 and SPID 6 (P < 0.01 and P < 0.001, respectively). Analysis of the stopwatch data reveale d that all active treatments displayed significantly more rapid onsets to c onfirmed first perceptible relief (P < 0.001 to < 0.05) and meaningful reli ef (P < 0.001 to < 0.01) than did placebo, with ibuprofen liquigel 400 mg d isplaying a significantly more rapid onset to meaningful relief than acetam inophen 1000 mg (P < 0.05) and a significantly more rapid onset to confirme d first perceptible relief than acetaminophen 1000 mg (P < 0.001) and ibupr ofen liquigel 200 mg (P < 0.01). All adverse events were considered mild or moderate, with an overall incidence of 11.5% in the ibuprofen liquigel 200 -mg group, 6.8% in the ibuprofen liquigel 400-mg group, 19.0% in the acetam inophen 1000-mg group, and 25.9% in the placebo group. Conclusions: Ibuprofen liquigel provided greater peak and overall analgesic effects and a more rapid onset to analgesia than did acetaminophen 1000 mg .