Overview

Rapid Agitation Control With Ketamine in the Emergency Department

Status:
Completed
Trial end date:
2020-03-12
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
David Barbic
Collaborators:
Centre for Health Evaluation and Outcome Sciences (CHÉOS)
St Paul's Emergency Department Research Fund
Treatments:
Haloperidol
Haloperidol decanoate
Ketamine
Midazolam
Criteria
Inclusion Criteria:

1. Age 19 - 60 years inclusively;

2. Patients presenting to the emergency department with psychomotor agitation or violent
behaviour (RASS score > +3).

Exclusion Criteria:

1. Less than 19 years of age;

2. Greater than 60 years of age;

3. Previous participation in this study;

4. Women suspected or known to be pregnant or breastfeeding;

5. Previous known hypersensitivity, intolerance or allergy to ketamine, midazolam or
haloperidol or their components.

6. Subjects who are in comatose states or have CNS depression due to alcohol or are
taking other depressant drugs.

7. Subjects with severe depressive states, spastic diseases and in Parkinson's syndrome,
except in the case of dyskinesias due to levodopa treatment.

8. Senile patients with pre-existing Parkinson-like symptoms.

9. Subjects with a history of cerebrovascular accident

10. Subjects in whom a significant elevation of blood pressure would constitute a serious
hazard, such as patients with significant hypertension

11. Subjects with severe cardiac decompensation

12. Subjects who intend to have surgery of the pharynx, larynx, or bronchial tree unless
adequate muscle relaxants are used

13. Subjects with acute pulmonary insufficiency

14. Subjects with severe chronic obstructive pulmonary disease

15. Subjects with acute narrow angle glaucoma