A DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL COMPARING THE ANALGESIC EFFICACY OF 2 FORMULATIONS OF DICLOFENAC IN POSTOPERATIVE DENTAL PAIN

A double-blind, randomized, parallel-group, placebo-controlled study was conducted to compare the analgesic effect of single doses (50 mg) of enteric-coated diclofenac sodium with a new sugar-coated formulation, diclofenac potassium, in 151 adults suffering from moderate to severe pain after extraction of an impacted third molar. Efficacy was assessed over an observation period of 6 hours using verbal rating scales for pain intensity and pain relief. Both diclofenac potassium and diclofenac sodium led to significant reductions from baseline in the mean pain intensity scores starting at 15 minutes and 2 hours, respectively, after dosing; a similar trend was also seen for the mean pain relief scores. Derived indices from the pain intensity/pain relief scores indicated a faster onset and better analgesic effect of diclofenac potassium compared with that achieved with diclofenac sodium with both active medications being superior to placebo. The number of patients reporting drug-related adverse experiences was one with diclofenac sodium and three each with diclofenac potassium and placebo. We conclude that both diclofenac formulations are effective in relieving postoperative dental pain; however, diclofenac potassium may be more suitable for the treatment of acute painful disorders in which a quick onset of analgesic effect is both expected and desirable.