1 / 5

Annals of Emergency Medicine, Jan 2013, Volume 61, No. 1, p 72-81

Intravenous Droperidol or Olanzapine as an Adjunct to Midazolam for the Acutely Agitated Patient: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Clinical Trail. Annals of Emergency Medicine, Jan 2013, Volume 61, No. 1, p 72-81. Introduction & Background.

shira
Download Presentation

Annals of Emergency Medicine, Jan 2013, Volume 61, No. 1, p 72-81

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Intravenous Droperidol or Olanzapine as an Adjunct to Midazolam for the Acutely Agitated Patient: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Clinical Trail Annals of Emergency Medicine, Jan 2013, Volume 61, No. 1, p 72-81

  2. 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.)

  3. 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 sedationSecondary outcome: need for additional sedation, need for resedation, total midazolam used, QTc, ED length of stay and adverse events

  4. 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

  5. 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

More Related