The efficacy and safety of single oral 15, 30, and 60 mg doses of
ciramadol, an investigational agonist/antagonist
analgesic, were studied in a
postoperative pain model and compared with
aspirin, 325 and 650 mg. Two visual analog
pain assessment scales were also compared. Results showed that a
pain relief score of moderate or better was reported at some time during the 6-hour observation period by 76% of the patients who took 15 mg
ciramadol, by 60% of those who took 30 mg
ciramadol, by 59% of those who took 60 mg
ciramadol, and by 38% and 92% of the patients who took the low and high doses of
aspirin, respectively. From 1 to 4 hours after
drug dosing, 15 mg
ciramadol generally produced higher scores, indicative of greater
pain relief, on the three
pain intensity efficacy scales used (verbal, linear analog, and curvilinear analog) than did the other two
ciramadol doses, but these differences were generally not significant. The differences between 15 mg
ciramadol and 650 mg
aspirin were generally not significant, although the higher
aspirin dose had some advantages over 15 mg
ciramadol. The most frequently reported adverse effect was
dizziness/
vertigo in 22% of patients taking 60 mg
ciramadol, in 17% of those taking 30 mg
ciramadol, in 13% of those taking 15 mg
ciramadol, in 4% of those taking high
aspirin doses, and in none of those who received the low
aspirin doses. The correlation coefficient for the linear and curvilinear
pain analog intensity scales was 0.955, indicating a highly significant correlation (P less than 0.001).