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.