Abstract. Objective: Informed consent is a required part of clinical research. Industry consent forms may be complex and difficult to understand. A comparison was performed between a standard, industry consent form (IF) and a modified, shortened version of the same form (MF) to determine which allows the patient to retain more information in the immediate postconsent period. Methods: This was a prospective, randomized study performed in an urban, county teaching emergency department (ED). A convenience sample (based on the availability of one of two research assistants being present in the ED) of 100 patients with a history of asthma seen in the ED were enrolled. After reading the consent form, 50 MF and 50 IF patients were given a postconsent test to determine how much information was retained. Mean differences in test scores between the IF and MF were determined. Results: The population had a mean age (ϮSD) of 39.4 Ϯ 12.1 years (range 18-80); 52% were female. The overall score for the study population was 9.6 (Ϯ2.0), range 2-12 (maximum 12). The MF score was 10.6 (Ϯ1.4) vs the IF score of 8.6 (Ϯ2.1); mean difference = 2.0 (95% CI = 1.3 to 2.7, p < 0.0001). The MF group had significantly more correct answers than the IF group with the following questions (MF%, IF%; mean difference in proportions with 95% CIs): purpose (96, 70; 26, 95% CI = 12 to 40); randomization (78, 44; 34, 95% CI = 16 to 52); study duration (94, 70; 24, 95% CI = 10 to 38); risks (92, 74; 18, 95% CI = 4 to 32); benefits (94, 78; 16, 95% CI = 3 to 29); alternative treatments (88, 70; 18, 95% CI = 2 to 34); confidentiality (98, 88; 10, 95% CI = 0.2 to 20); and voluntary participation (74, 54; 20, 95% CI = 2 to 38). Adverse event compensation had the poorest correct rate (54, 38; 13, 95% CI = Ϫ6 to 32). Subsequently, after taking the postconsent test, 98% wrote that they read the entire MF, while only 68% wrote that they read the entire IF (mean difference in proportions 30%, 95% CI = 17% to 43%). Conclusions: Compared with an industry consent form, a shortened version, focusing on Food and Drug Administration and Department of Health and Human Services informed consent guidelines, allowed patients to retain more information in the immediate postconsent period.

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Objectives: To determine if midazolam is superior to lorazepam or haloperidol in the management of violent and severely agitated patients in the emergency department. Superiority would be determined if midazolam resulted in a significantly shorter time to sedation and shorter time to arousal. Methods: This was a randomized, prospective, double-blind study of a convenience sample of patients from an urban, county teaching emergency department. Participants included 111 violent and severely agitated patients. Patients were randomized to receive intramuscular midazolam (5 mg), lorazepam (2 mg), or haloperidol (5 mg). Results: The mean (6SD) age was 40.7 (613) years. The mean (6SD) time to sedation was 18.3 (614) minutes for patients receiving midazolam, 28.3 (625) minutes for haloperidol, and 32.2 (620) minutes for lorazepam. Midazolam had a significantly shorter time to sedation than lorazepam and haloperidol (p < 0.05). The mean difference between midazolam and lorazepam was 13.0 minutes (95% confidence interval [95% CI] = 5.1 to 22.8 minutes) and that between midazolam and haloperidol was 9.9 minutes (95% CI = 0.5 to 19.3 minutes). Time to arousal was 81.9 minutes for patients receiving midazolam, 126.5 minutes for haloperidol, and 217.2 minutes for lorazepam. Time to arousal for midazolam was significantly shorter than for both haloperidol and lorazepam (p < 0.05). The mean difference in time to awakening between midazolam and lorazepam was 135.3 minutes (95% CI = 89 to 182 minutes) and that between midazolam and haloperidol was 44.6 minutes (95% CI = 9 to 80 minutes). There was no significant difference over time by repeated-measures analysis of variance between groups in regard to changes in systolic and diastolic blood pressure (p = 0.8965, p = 0.9581), heart rate (p = 0.5517), respiratory rate (p = 0.8191), and oxygen saturation (p = 0.8991). Conclusions: Midazolam has a significantly shorter time to onset of sedation and a more rapid time to arousal than lorazepam or haloperidol. The efficacies of all three drugs appear to be similar. Key words: agitation; emergency department; restraint; midazolam; haloperidol; lorazepam. ACADEMIC EMERGENCY MEDICINE 2004; 11:744-749. Violent and severely agitated patients (VSAPs) in the emergency department (ED) are a common and serious problem. In a survey of EDs, 32% reported receiving at least one verbal threat daily, 18% reported at least one threat with a weapon daily, and 25% reported restraining at least one patient each day. Seven percent of surveyed institutions had experienced a death secondary to violent behavior in the ED within the previous five years, and 80% had one or more staff members injured due to violence during the same period.1 The urban, county ED where this study was based provides care for a sizable substance and alcohol abusing population and also offers medical clearance services for county emergency psychiatric patients. Consequently, our ED encounters a significant number of VSAPs for a variety of medical and other reasons. Most V...