CompletedPhase 2

Rapid Agitation Control With Ketamine in the Emergency Department

Canada81 participantsStarted 2018-05-29

Plain-language summary

Compare intramuscular (IM) ketamine to a combination of IM midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the emergency department with psychomotor agitation and violent behavior.

Who can participate

Age range19 Years – 60 Years

SexALL

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Inclusion criteria

✓. Age 19 - 60 years inclusively;
✓. Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score \> +3).

Exclusion criteria

✕. Less than 19 years of age;
✕. Greater than 60 years of age;
✕. Previous participation in this study;
✕. Women suspected or known to be pregnant or breastfeeding;
✕. Previous known hypersensitivity, intolerance or allergy to ketamine, midazolam or haloperidol or their components.
✕. Subjects who are in comatose states or have CNS depression due to alcohol or are taking other depressant drugs.
✕. Subjects with severe depressive states, spastic diseases and in Parkinson's syndrome, except in the case of dyskinesias due to levodopa treatment.
✕. Senile patients with pre-existing Parkinson-like symptoms.

What they're measuring

Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.

Timeframe: 1 day

Trial details

NCT IDNCT03375671

SponsorDavid Barbic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-12

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