Double-blind crossover study of the efficacy and acceptability of oxazepam Expidet tablets compared to placebo in patients undergoing gynaecological surgery.
In a double-blind crossover trial, the hypnotic efficacy and acceptability of oxazepam Expidet, a fast-dissolving tablet, was compared to placebo in patients undergoing minor gynaecological surgery. Patients received 30 mg oxazepam Expidet or placebo the night before their operation and the alternate medication the night after. A sleep questionnaire was completed the morning after both nights and acceptability was assessed the morning after the second night. Data were available for analysis on seventy-two patients aged 18-50 years. There was a significant improvement in sleep onset and quality and less awakenings after oxazepam compared to placebo (p less than or equal to 0.01). There was no significant difference in the occurrence or type of dreams, or morning-after symptoms. There was a significant preference for oxazepam compared to placebo and for the fast-dissolving Expidet form compared to conventional tablets or capsules (p less than or equal to 0.01). There were no adverse reactions in the oxazepam group. It was concluded that oxazepam Expidet was an effective and acceptable hypnotic in this group of patients.
D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005831:Genital Diseases, Female / Q000601:surgery*; D006801:Humans; D008875:Middle Aged; D010076:Oxazepam / Q000009:adverse effects / Q000627:therapeutic use*; D011229:Preanesthetic Medication; D011897:Random Allocation; D012890:Sleep / Q000187:drug effects; D013693:Temazepam / Q000627:therapeutic use
D010076:Oxazepam; D013693:Temazepam