Open AccessEfficacy and tolerability of diclofenac potassium sachets in acute postoperative dental pain: a placebo‐controlled, randomised, comparative study vs. diclofenac potassium tablets
Author(s) -
Hofele C. M.,
Gyenes V.,
Daems L. N.,
StypulaCiuba B.,
Wagener H.,
Siegel J.,
Edson K.
Publication year - 2006
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/j.1368-5031.2006.00828.x
Subject(s) - medicine , placebo , diclofenac , analgesic , tolerability , visual analogue scale , anesthesia , randomized controlled trial , surgery , adverse effect , alternative medicine , pathology
Summary 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 remedicated 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.