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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03375671
Other study ID # H17-00571
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 29, 2018
Est. completion date March 12, 2020

Study information

Verified date November 2020
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date March 12, 2020
Est. primary completion date March 12, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 60 Years
Eligibility 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 Design


Intervention

Drug:
Ketalar
single administration of 5 mg/kg, IM
Midazolam injection
single administration of 5 mg, IM
Haloperidol
single administration of 5 mg, IM

Locations

Country Name City State
Canada St. Paul's Hospital Emergency Department Vancouver British Columbia

Sponsors (3)

Lead Sponsor Collaborator
David Barbic Centre for Health Evaluation and Outcome Sciences (CHÉOS), St Paul's Emergency Department Research Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1. Measured using Richmond Agitation Sedation Scale (RASS) in each arm 1 day
Secondary Percentage participants with adverse events in each arm measured by AE collection in each arm up to 4 days
Secondary Percentage of participants in each arm requiring rescue medications between 5 and 30 minutes (at 5 minutes interval) after study medication(s) administration by count. measured by rescue medication administration 1 day
Secondary Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria measured using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) criteria 1 day
Secondary Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm. measured by occurrence of neuroleptic malignant syndrome 1 day
Secondary Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint. measured by police account at study enrollment 1 day
Secondary Participant experience survey outcomes. measured using Participant Experience Survey 1 day
Secondary Study Nurse Experience survey outcomes. measured using Study Nurse Experience Survey 1 day
Secondary Effectiveness of Blinding survey outcomes measured using Effectiveness of Study Drug Blinding Survey 1 day
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