PICENADOL IN A LARGE MULTICENTER DENTAL PAIN STUDY

Study Objective. To estimate the analgesic dose of picenadol hydrochloride equal to codeine 60 mg in a dental pain model. Design. Randomized, double-blind, parallel, dose-response study. Setting. Four university-based dental clinics. Patients. Four hundred eight adult patients with moderate or severe pain after extraction of one or more impacted molar teeth plus bone removal. Interventions. Patients received orally administered single doses of picenadol 15 and 30 mg, codeine phosphate 30 and 90 mg, or placebo. Methods. Single oral doses of picenadol 15 and 30 mg, an opioid agonist-antagonist, were compared with codeine 30 and 90 mg and placebo in 408 patients with moderate or severe pain from third molar extraction in a randomized, double-blind, parallel study. Assessments were performed for pain intensity, pain relief, and adverse events for up to 6 hours after drug administration. Main Results. Picenadol 30 mg and codeine 90 mg were more effective than placebo based 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 codeine 90 mg (p<0.05). No patients discontinued due to adverse events, and all such events resolved spontaneously. Conclusions. Picenadol 22 mg was estimated to be equianalgesic to codeine 60 mg, and picenadol 30 mg was safe in this dental pain model.