A Double-Blind Comparison of Multiple Intramuscular Doses of Ciramadol, Morphine, and Placebo for the Treatment of Postoperative Pain

Abstract

Ciramadol, an agonist-antagonist analgesic (in intramuscular doses of 30 and 60 mg) was compared with 10 mg of morphine and placebo in a double-blind, parallel study in 160 patients with postoperative pain. The patients were assigned randomly to one of the four treatment groups and could receive a dose of the medication every 3 hr as needed for 48 hr; a maximum of six doses was allowed in a 24-hr period. Formal efficacy assessments using standard pain intensity and pain relief scales were restricted to the initial dose period. The three active therapy groups had significantly (P less than 0.05) higher analgesia scores than the placebo group on all efficacy scales. The mean cumulative efficacy scores for the initial dose evaluation were highest for 60 mg of ciramadol; however, patients' overall evaluations of therapy were highest in the morphine group. Nausea and vomiting were the most frequent adverse experiences (15-25% incidence); however, there were no statistically significant differences between groups in their occurrence. A greater percentage (P less than 0.05) of patients reported skin reactions in the 60 mg ciramadol group (15%) than in the 30 mg ciramadol (0%) and placebo (0%) groups. Sedation was slightly higher with the active therapies than with placebo. Changes in vital signs were minimal. It is concluded that 60 mg of ciramadol compares favorably with 10 mg of morphine as a postoperative analgesic.