Efficacy and tolerability of diclofenac potassium sachets in acute postoperative dental pain: a placebo-controlled, randomised, comparative study vs. diclofenac potassium tablets.
This double-blind, randomised, parallel-group trial compared the analgesic efficacy of single 50 mg doses of diclofenac potassium sachets and tablets with placebo in 184 patients with moderate/severe pain after third molar extraction. The primary efficacy variable was the average pain reduction from baseline during the first 2-h postdose, using a visual analogue scale (VAS). During the first 2-h postdose, sachets and tablets significantly reduced pain (p < 0.05) vs. placebo with an incremental benefit seen for sachets over tablets (p < 0.05). Onset of analgesic effect (VAS) was at 30 min for sachets and 45 min for tablets. Pain reduction vs. placebo (VAS) was maintained for 8 h for sachets and tablets (p < 0.05). VAS-findings were confirmed by pain relief and intensity verbal scale assessments. Fewer patients re-medicated vs. placebo. No safety issues were identified. This study demonstrates that both diclofenac potassium sachets and tablets offer patients suffering from acute pain conditions an effective treatment with incremental analgesic benefits seen for sachets.
Hofele
C M
CM
Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Heidelberg, Im Neuenheimer Feld, Heidelberg, Germany. chofele@med.uni-heidelberg.de
Gyenes
V
V
Daems
L N
LN
Stypula-Ciuba
B
B
Wagener
H
H
Siegel
J
J
Edson
K
K
D000293:Adolescent; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008964:Molar, Third; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control*; D013607:Tablets; D014081:Tooth Extraction / Q000009:adverse effects*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D004008:Diclofenac