Randomized clinical trial comparing intravenous midazolam and droperidol for sedation of the acutely agitated patient in the emergency department.
OBJECTIVE
We compare intravenous midazolam and droperidol for the onset of sedation of acutely agitated patients in the emergency department (ED).


METHODS
This was a double-blind, randomized, clinical trial set in the ED of a university teaching hospital. Subjects were adults, acutely agitated because of mental illness, intoxication, or both, who received midazolam or droperidol, 5 mg intravenously, every 5 minutes until sedated. We analyzed time to sedation using survival analysis, median times to sedation, and proportions sedated at 5 and 10 minutes.


RESULTS
Seventy-four patients received midazolam; 79 patients, droperidol. Survival analysis showed no difference in time to sedation (hazard ratio 0.86; 95% confidence interval [CI] 0.61 to 1.23), P=.42. Median time to sedation was 6.5 minutes for midazolam (median dose 5 mg) and 8 minutes for droperidol (median dose 10 mg), P=.075 (effect size 1.5 minutes; 95% CI 0 to 4 minutes). At 5 minutes, 33 of 74 (44.6%) patients from the midazolam group were adequately sedated compared with 13 of 79 (16.5%) patients from the droperidol group, a difference of 28.1% (95% CI 12.9% to 43.4%; P<.001). By 10 minutes, 41 of 74 (55.4%) from the midazolam group were sedated compared to 42 of 79 (53.2%) from droperidol, a difference of 2.2% (95% CI -14.9% to 19.3%; P=.91). Eleven adverse events occurred in the midazolam group and 10 in the droperidol group. Three patients required active airway management (3 patients with assisted ventilation and 1 patient intubated); all received midazolam.


CONCLUSIONS
There is no difference in onset of adequate sedation of agitated patients using midazolam or droperidol. Patients sedated with midazolam may have an increased need for active airway management.
Knott
Jonathan C
JC
Emergency Medicine Research Unit, Royal Melbourne Hospital, Parkville, Victoria, Australia. jonathan.knott@mh.org.au
Taylor
David McD
DM
Castle
David J
DJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D001049:Apnea / Q000139:chemically induced; D001145:Arrhythmias, Cardiac / Q000139:chemically induced; D002320:Cardiovascular Physiological Phenomena / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004329:Droperidol / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004421:Dystonia / Q000139:chemically induced; D004635:Emergency Medicine / Q000295:instrumentation*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D007275:Injections, Intravenous; D008297:Male; D008874:Midazolam / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008875:Middle Aged; D011595:Psychomotor Agitation / Q000188:drug therapy*; D012008:Recurrence; D016019:Survival Analysis
D006993:Hypnotics and Sedatives; D004329:Droperidol; D008874:Midazolam