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Intravenous Droperidol or Olanzapine as an Adjunct to Midazolam for the Acutely Agitated Patient: A Multicentre, Randomized, Double-Blind, PlaceboControlled Clinical Trail Annals of Emergency Medicine, Jan 2013, Volume 61, No. 1, p 72-81 Introduction & Background Agitation and aggression common in ED due to mental illness, drug/alcohol intoxication, or both Studies in ED have compared benzo’s vs. antipsychotics Combination therapy? - limited data, most in non ED settings “black box” doperidol – prolonged QT and torsades des pointes, olanzapine i.v. (instead of i.m.) Material & Methods Multicentre, randomized, double-blind, placebo controlled, double dummy clinical trial Inclusion criteria: 18-65 y/old with need for i.v. drugs sedation for acute agitation Exclusion criteria: hypersensitivity, reversible cause for agitation, pregnancy, acute alcohol withdrawal One of 3 groups of drugs: Control group: placebo-droperidol, placebo-olanzapine Droperidol group: droperidol 5mg, placebo-olanzapine Olanzapine group: placebo-droperidol, olanzapine 5mg All followed by midazolam, 2.5mg <50kg, 5mg >50kg, max. 20mg Sedation measured by 6-point, validated sedation scale, =<2 Primary outcome: time to adequate sedation Secondary outcome: need for additional sedation, need for resedation, total midazolam used, QTc, ED length of stay and adverse events Results 336 enrolled patients, similar baseline characteristics Time to adequate sedation for droperidol and olanzapine significantly shorter: 4 min and 5 min % pts sedated at 5 min similar for all groups, at 10min more pts sedated w/droperidol or olanzapine No difference in need for addition sedation, more resedation in control group Similar adverse event rates in all groups, no serious a/e, no QTc changes Conclusion & Discussion Limitations: Selection bias Observer bias with use of scale Droperidol vs. olanzapine Intravenous route not always possible Conclusion: i.v. droperidol or olanzapine as adjunct to i.v. midazolam is efficacious and safe and provides more rapid sedation for acutely agitated patients in the ED Further studies to compare use of i.v. olanzapine alone with other sedative