Ketamine, Violent Aggressive Behavior
Conditions
Keywords
ketamine, aggressive behaviour, midazolam, haloperidol, emergency department
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 emergency department with psychomotor agitation and violent behavior.
Interventions
DRUGKetalar
single administration of 5 mg/kg, IM
DRUGMidazolam injection
single administration of 5 mg, IM
DRUGHaloperidol
single administration of 5 mg, IM
Sponsors
St Paul's Emergency Department Research Fund
Centre for Health Evaluation and Outcome Sciences (CHÉOS)
David Barbic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1. | 1 day | Measured using Richmond Agitation Sedation Scale (RASS) in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 day | measured by rescue medication administration |
| Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria | 1 day | measured using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) criteria |
| Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm. | 1 day | measured by occurrence of neuroleptic malignant syndrome |
| Percentage participants with adverse events in each arm | up to 4 days | measured by AE collection in each arm |
| Participant experience survey outcomes. | 1 day | measured using Participant Experience Survey |
| Study Nurse Experience survey outcomes. | 1 day | measured using Study Nurse Experience Survey |
| Effectiveness of Blinding survey outcomes | 1 day | measured using Effectiveness of Study Drug Blinding Survey |
| Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint. | 1 day | measured by police account at study enrollment |
Countries
Canada
Outcome results
None listed