[Efficacy and tolerability 80 mg granulated ketoprofen lysine salt in posttraumatic orodental pain: double blind vs placebo study].

A randomized, double-blind parallel group, placebo-controlled study was carried out in order to evaluate the analgesic and antiin-flammatory activity of ketoprofen lysine salt as granular formulation. Sixty patients undergoing extraction of an impacted third molar were treated orally with 80 mg ketoprofen lysine salt sachet or placebo t.i.d. for 3 days. The inflammation related local signs (pain, flare, local heat and wheal) were evaluated by scores at 1th and 3th day of observation; to study the time-course of analgesic activity, pain intensity was evalauted by Visual Analogic-Scale (VAS) by Scott-Huskisson before and 0.30 minutes, 1, 2, 3, 4, 5, 6, 8 hours after the first administration. Ketoprofen lysine salt was significantly superior to placebo in reducing all inflmamtory signs and symptoms starting from the first day of treatment; the analgesic effect was evident already 30 minutes after administration. Investigator's and patient's global evaluations of efficacy resulted favourable for ketoprofen lysine salt in 96.6% and for placebo in 26.7%. The three adverse events reported were limited to gastric pyrosis (ketoprofen lysine salt, two patients; placebo one patient) and posed no problem to patient management. These data demonstrate the pronouced and rapid analgesic and antinflammatory activity of 80 mg ketoprofen lysine salt granular formulation in post-operative pain and inflammation associated with dental surgery.