CompletedPhase 2ketamine
Rapid Agitation Control With Ketamine in the Emergency Department
Sponsored by David Barbic
NCT ID
NCT03375671
Target Enrollment
81 participants
Start Date
2018-05-29
Est. Completion
2020-03-12
About This Study
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.
Conditions Studied
Interventions
- •Ketalar
- •Midazolam injection
- •Haloperidol
Eligibility
Age:19 Years - 60 Years
Healthy Volunteers:No
View full eligibility 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
Study Locations (1)
St. Paul's Hospital Emergency Department
Vancouver, British Columbia, Canada