Status:
COMPLETED
Rapid Agitation Control With Ketamine in the Emergency Department
Lead Sponsor:
David Barbic
Collaborating Sponsors:
St Paul's Emergency Department Research Fund
Centre for Health Evaluation and Outcome Sciences (CHÉOS)
Conditions:
Violent Aggressive Behavior
Ketamine
Eligibility:
All Genders
19-60 years
Phase:
PHASE2
Brief 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 emerge...
Eligibility Criteria
Inclusion
- Age 19 - 60 years inclusively;
- Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score \> +3).
Exclusion
- 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.
- Subjects with a history of cerebrovascular accident
- Subjects in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension
- Subjects with severe cardiac decompensation
- Subjects who intend to have surgery of the pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used
- Subjects with acute pulmonary insufficiency
- Subjects with severe chronic obstructive pulmonary disease
- Subjects with acute narrow angle glaucoma
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2020
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03375671
Start Date
May 29 2018
End Date
March 12 2020
Last Update
November 30 2020
Active Locations (1)
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1
St. Paul's Hospital Emergency Department
Vancouver, British Columbia, Canada, V6Z 1Y6