Oral ciramadol in the treatment of postoperative pain.
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).
D000293:Adolescent; D000328:Adult; D000588:Amines / Q000627:therapeutic use*; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use; D001596:Benzylamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*; D011897:Random Allocation; D013997:Time Factors
D000588:Amines; D000700:Analgesics; D001596:Benzylamines; C018273:ciramadol; D001241:Aspirin