Abstract
Bromfenac, a new non-opioid analgesic agent, in single oral doses of 25 and 50mg was compared with tramadol 100mg and placebo in the treatment of 130 outpatients with moderate or severe pain after oral surgery. Patients rated their pain intensity and pain relief for up to 8 hours after medication. Bromfenac at 25 and 50mg doses was superior to tramadol 100mg and placebo. Pain relief was significantly (p < 0.05) higher than that with tramadol 100mg and placebo 30 minutes after dose administration, and the difference remained significant for 6 to 8 hours. Patients who received bromfenac reported more favourable global responses to therapy than did those who received tramadol 100mg or placebo. The responses to tramadol 100mg were not distinguishable from placebo for any of the efficacy variables. Adverse events were infrequent but significantly (p < 0.05) more patients in the tramadol group than in the bromfenac 50mg group reported events: 7 patients in the tramadol group vs 1 patient in the bromfenac group. Four patients in the tramadol group reported digestive adverse events (dyspepsia, nausea, vomiting) compared with no patients in either of the bromfenac treatment groups (p < 0.05). The results indicate that a single oral dose of bromfenac 25 or 50mg is more efficacious and better tolerated than tramadol 100mg.
Published Version
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