Clinical comparison of dexketoprofen trometamol and dipyrone in postoperative dental pain

A total of 125 outpatients with moderate to severe pain after surgical remo val of one impacted third molar were randomly assigned to receive dexketopr ofen trometamol 12.5 or 25 mg or dipyrone 575 mg. For first-dose assessment s, patients rated their pain intensity and its relief at regular intervals. From 60 min post dose to the end of the 6-h observation period, both doses of dexketoprofen trometamol had higher pain relief scores than dipyrone: B etween 3 and 6 h the differences were statistically significant. In additio n, peak measures (PIDmax and PAR(max)) were statistically superior after bo th doses of dexketoprofen trometamol compared to dipyrone. The overall effi cacy assessed at the end of the first-dose phase was rated as good or excel lent by 90%, 83.3%, and 70% of patients receiving dexketoprofen trometamol 25 mg, dexketoprofen trometamol 12.5 mg, and dipyrone, respectively. The nu mber of patients who required remedication during the 6-h period was signif icantly lower in both dexketoprofen groups. Repeated-dose data were also ob tained. No significant differences were found in the efficacy after repeate d doses, the number of doses taken, or the mean time elapsed between doses. The overall efficacy at the end of the repeated-dose phase was rated as go od or excellent by 84.2%, 66.7%, and 70% of patients receiving dexketoprofe n trometamol 25 mg dexketoprofen trometamol 12.5 mg, and dipyrone, respecti vely. The frequency of adverse events was similar for all treatments and no serious adverse events were reported during the study. Journal of Clinical Pharmacology, 1998;38:55S-64S (C) 1998 The American College of Clinical Ph armacology.