Pj. Desjardins et al., BROMFENAC, A NONOPIOID ANALGESIC, COMPARED WITH TRAMADOL AND PLACEBO FOR THE MANAGEMENT OF POSTOPERATIVE PAIN, Clinical drug investigation, 15(3), 1998, pp. 177-185
Bromfenac, a new non-opioid analgesic agent, in single oral doses of 2
5 and 50mg was compared with tramadol 100mg and placebo in the treatme
nt 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 tram
adol 100mg and placebo. Pain relief was significantly (p < 0.05) highe
r than that with tramadol 100mg and placebo 30 minutes after dose admi
nistration, and the difference remained significant for 6 to 8 hours.
Patients who received bromfenac reported more favourable global respon
ses 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 t
he bromfenac 50mg group reported events: 7 patients in the tramadol gr
oup 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 100
mg.