Efficacy and safety of the
analgesic ciramadol in the management of
postoperative pain was evaluated in 139 healthy patients given single, double-blind,
intramuscular injections of either 30 mg
ciramadol, 60 mg
ciramadol, 10 mg
morphine or
0.9% saline on the first or second postoperative day. Differences in
pain intensity and relief of
pain, changes from baseline on a
pain analog scale, percentage of patients with moderate or greater
pain relief, and cumulative treatment failures were measured for 6 hours after injection.
Morphine proved to be superior to all other treatments. Neither dose of
ciramadol could be statistically differentiated from placebo. During the first hour after administration, some measurements showed that 30 mg
ciramadol was superior to 60 mg
ciramadol. Patients experienced little or no drowsiness in any of the four groups, and other side effects were transient and required no specific
therapy. Some patients experienced an acute increase in
pain intensity after administration of 60 mg
ciramadol; this possibly represents antagonism of the residual effect of the previous
narcotic. This study must be interpreted with the knowledge that
ciramadol, an agonist-antagonist
analgesic, was administered to patients who had been receiving
narcotic analgesics before entering the study. Future studies of
ciramadol given as the sole
analgesic may more clearly define its efficacy in the management of
postoperative pain.