In the present study a statistically significant effect of ginger extract could only be demonstrated by explorative statistical methods in the first period of treatment before cross-over, while a significant difference was not observed in the study as a whole.
Dyloject is a novel formulation of diclofenac intended for intravenous ( IV) administration. This formulation employs the solubilizing agent hydroxypropyl-b-cyclodextrin to permit bolus IV administration. The efficacy and safety of 5 dose levels of IV diclofenac were compared with IV ketorolac and placebo following third molar extraction. This was a single-dose, randomized, double-blind, placeboand comparator-controlled, parallel-group study. A total of 353 subjects with moderate to severe pain received placebo; ketorolac 30 mg; or IV diclofenac 3.75, 9.4, 18.75, 37.5, or 75 mg (N 5 51 for all groups, except N 5 47 for ketorolac). The primary endpoint was total pain relief over 6 hours ( TOTPAR6 ) as measured by the visual analog scale (VAS). Secondary endpoints included multiple measures of pain intensity and relief; patient global evaluation; and times to pain relief and rescue medication. Dropouts and adverse effects ( AEs) were also monitored. IV diclofenac was superior to placebo as measured by TOTPAR6 (P , .0001 for all doses except 3.75 mg, for which P 5 .0341). IV diclofenac 3.75 mg was statistically superior to placebo for TOTPAR2 and TOTPAR4. IV diclofenac at both 37.5 and 75 mg was superior to placebo (P , .05) at the earliest (5 minute) assessments of pain intensity and pain relief, but ketorolac was not. The proportion of patients reporting 30% or greater pain relief at 5 minutes was significantly greater after IV diclofenac 37.5 and 75 mg than after ketorolac 30 mg or placebo. Secondary endpoints confirmed the primary findings. Treatment-related AEs were generally mild to moderate and were typical for nonsteroidal anti-inflammatory drugs (NSAIDs). The more rapid onset of action of IV diclofenac compared with the reference injectable NSAID ketorolac suggests additional clinical benefit. If confirmed in larger series, these findings may improve the safety and efficacy of postoperative NSAID analgesia.
The analgesic efficacy of the cyclooxygenase-2 specific inhibitors, valdecoxib and rofecoxib, were evaluated in patients following oral surgery. In a randomized, double-blind, controlled trial, patients experiencing moderate or severe pain received single-dose valdecoxib 40 mg (n=99), rofecoxib 50 mg (n=101), or placebo (n=50) within 4 hours after multiple third molar extraction with bone removal. Onset of action was significantly faster with valdecoxib 40 mg (30 minutes) compared with rofecoxib 50 mg (45 minutes), as measured by pain intensity difference and pain relief scores (P
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