Propiram and codeine in episiotomy pain

Abstract

To evaluate relative efficacy, safety, and time course of analgesia, propiram fumarate (50 and 100 mg), a new narcotic agonist-antagonist, was compared with codeine sulfate (60 mg) and placebo in a clinical trial with a single peroral dose, parallel, stratified, randomized, and double-blind design involving 80 hospitalized postpartum women with medium or severe episiotomy pain. Using verbal subjective reports as index of response, patients rated pain intensity and side effects at periodic interviews for 6 h. Relative efficacy findings based on peak effects and summed pain-intensity differences suggested dose-dependent analgesia with propiram and also that 60 mg codeine lay between 50 mg propiram and placebo. Moreover, after 50 or 100 mg propiram, 8 of 20 patients reported greater than 50% reduction of initial pain compared with 7 of 20 after 60 mg codeine and 2 of 20 after placebo. After each of the propiram doses, distinct analgesia began within 1/2 h and reached peak effect between 1 h (p less than 0.02) and 2 h (p less than 0.05). After f60 mg codeine, onset was slower and peak later (4 h, p less than 0.05). All three active drugs continued to act until the 5th or 6th h. Drowsiness was the only statistically significant side effect reported after propiram. These results suggest that single 50 or 100 mg doses of propiram were effective in episiotomy pain, induced stronger analgesia than 60 mg codeine, and took effect more rapidly.