Transcript Intravenous Droperidol or Olanzapine as an

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
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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
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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:
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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
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336 enrolled patients, similar baseline characteristics
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Time to adequate sedation for droperidol and
olanzapine significantly shorter: 4 min and 5 min
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% pts sedated at 5 min similar for all groups, at 10min
more pts sedated w/droperidol or olanzapine
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No difference in need for addition sedation, more
resedation in control group
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Similar adverse event rates in all groups, no serious
a/e, no QTc changes
Conclusion & Discussion
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Limitations:
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Selection bias
Observer bias with use of scale
Droperidol vs. olanzapine
Intravenous route not always possible
Conclusion:
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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