Double-Blind Oral Analgesic Study of Butorphanol in Episiotomy Pain: A Comparison with Codeine and Placebo

Abstract

Butorphanol tartrate (8 mg and 16 mg), codeine phosphate (60 mg) and placebo were compared for oral analgesic activity and side-effects employing a double-blind design in 127 hospitalized women suffering from moderate to very severe post-partum episiotomy pain. The study duration was 24 hours with medication administered every 6 hours for a total of four doses per patient. The results demonstrate that butorphanol 8 mg, 16 mg and codeine 60 mg were all significantly better than placebo (p<0.05). The data indicate that both doses of butorphanol were longer-acting than codeine as determined by significant activity over codeine at the longer time intervals (4, 5 and 6 hours) after dosing. The onset of activity appeared to be 1 hour for butorphanol 8 mg as well as codeine 60 mg and 1/2 hour for butorphanol 16 mg. The peak effect occurred at 2 hours for all treatments. The duration of effect appeared to be 4 hours for codeine 60 mg, and longer, possibly 5 to 6 hours, for butorphanol 8 and 16 mg. All of the active treatments significantly improved the patient's ability to “get a good night's sleep” which was impaired before treatment. The longer duration of action for butorphanol 8 and 16 mg over codeine 60 mg was also reflected in these parameters. Generally, the incidence of side-effects in this study was low with the active treatments presenting a higher incidence than placebo but similar to each other. No serious side-effects were observed in this study. The most common side-effects were drowsiness for butorphanol and nausea for codeine.