PICENADOL IN A LARGE MULTICENTER DENTAL PAIN STUDY

Study Objective. To estimate the analgesic dose of picenadol hydrochlo ride equal to codeine 60 mg in a dental pain model. Design. Randomized , double-blind, parallel, dose-response study. Setting. Four universit y-based dental clinics. Patients. Four hundred eight adult patients wi th moderate or severe pain after extraction of one or more impacted mo lar teeth plus bone removal. Interventions. Patients received orally a dministered single doses of picenadol 15 and 30 mg, codeine phosphate 30 and 90 mg, or placebo. Methods. Single oral doses of picenadol 15 a nd 30 mg, an opioid agonist-antagonist, were compared with codeine 30 and 90 mg and placebo in 408 patients with moderate or severe pain fro m third molar extraction in a randomized, double-blind, parallel study . Assessments were performed for pain intensity, pain relief, and adve rse events for up to 6 hours after drug administration. Main Results. Picenadol 30 mg and codeine 90 mg were more effective than placebo bas ed on sum of pain intensity differences, total pain relief, peak pain relief, and duration of analgesia (p<0.05). Compared with placebo, the frequency of adverse events was highest for patients receiving codein e 90 mg (p<0.05). No patients discontinued due to adverse events, and all such events resolved spontaneously. Conclusions. Picenadol 22 mg w as estimated to be equianalgesic to codeine 60 mg, and picenadol 30 mg was safe in this dental pain model.