Analgesic efficacy of low-dose diclofenac versus paracetamol and placebo in postoperative dental pain.
OBJECTIVE
To compare the efficacy and safety of diclofenac-K (12.5 mg) vs paracetamol (500 mg) and placebo given in a flexible dosage regimen to treat pain resulting from extraction of impacted third molar teeth.


METHODS
This was a 2-day, double-blind, double-dummy, randomized, parallel-group, placebo-controlled study of diclofenac-K (12.5 mg) tablets vs paracetamol (500 mg) tablets and placebo in patients with moderate or severe pain within 8 hours of extraction of impacted third molars.


RESULTS
After the first 2-tablet dose, patients took on average 2.5 additional tablets of diclofenac-K or 2.4 tablets of paracetamol, almost all as 1-tablet doses. Most placebo patients discontinued by taking rescue medication (ibuprofen 200 mg) on the first day. Pain relief after the initial dose of diclofenac-K (2 x 12.5 mg) was superior to placebo (P < .01 for all efficacy outcomes) and comparable to paracetamol (2 x 500 mg). About 30% of patients in each active treatment group took rescue medication during the study, compared to 78% on placebo. About 70% in each active treatment group considered the overall pain relief to be "some," "a lot," or "complete" compared to only 15% on placebo. The incidence of adverse events in each active treatment group was low and comparable between the treatments.


CONCLUSIONS
An initial double-dose of diclofenac-K (2 x 12.5 mg) or paracetamol (2 x 500 mg) adequately relieved the most intense postoperative pain, and the flexible multiple dose regimen (1 or 2 tablets) maintained adequate pain relief thereafter. Most patients needed only 1-tablet doses following the initial 2-tablet dose.
Kubitzek
Florian
F
Clinical Research and Development of Pharmaceuticals, Morge, Switzerland.
Ziegler
Gabrielle
G
Gold
Morris S
MS
Liu
Jiun-Min-H
JM
Ionescu
Elisabeta
E
D000082:Acetaminophen / Q000008:administration & dosage*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D019540:Area Under Curve; D016009:Chi-Square Distribution; D004008:Diclofenac / Q000008:administration & dosage*; D004311:Double-Blind Method; D005157:Facial Pain / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008964:Molar, Third / Q000601:surgery; D016017:Odds Ratio; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D014081:Tooth Extraction / Q000009:adverse effects; D014095:Tooth, Impacted / Q000601:surgery
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D000082:Acetaminophen