Picenadol in a large multicenter dental pain study.
OBJECTIVE
To estimate the analgesic dose of picenadol hydrochloride equal to codeine 60 mg in a dental pain model.


METHODS
Randomized, double-blind, parallel, dose-response study.


METHODS
Four university-based dental clinics.


METHODS
Four hundred eight adult patients with moderate or severe pain after extraction of one or more impacted molar teeth plus bone removal.


METHODS
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.


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.
Goldstein
D J
DJ
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285.
Brunelle
R L
RL
George
R E
RE
Cooper
S A
SA
Desjardins
P J
PJ
Gaston
G W
GW
Jeffers
G E
GE
Gallegos
L T
LT
Reynolds
D C
DC
D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D001842:Bone and Bones / Q000601:surgery; D003061:Codeine / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D010880:Piperidines / Q000627:therapeutic use*; D014081:Tooth Extraction
D000700:Analgesics; D010880:Piperidines; C035115:picenadol; D003061:Codeine