Clinical trial NCT03375671: Rapid Agitation Control With Ketamine in the Emergency Department
Official title: Rapid Agitation Control With Ketamine in the Emergency Department (RACKED): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Violent Aggressive Behavior
Ketamine
Keywords: ketamine
aggressive behaviour
midazolam
haloperidol
emergency department
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: St Paul's Emergency Department Research Fund
name: Centre for Health Evaluation and Outcome Sciences (CHÉOS)
First posted: 2017-12-18
Enrollment: 81
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.
timeFrame: 1 day
Secondary outcomes:
measure: Percentage participants with adverse events in each arm
timeFrame: up to 4 days
measure: 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.
timeFrame: 1 day
measure: Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria
timeFrame: 1 day
measure: Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.
timeFrame: 1 day
measure: Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint.
timeFrame: 1 day
measure: Participant experience survey outcomes.
timeFrame: 1 day
measure: Study Nurse Experience survey outcomes.
timeFrame: 1 day
measure: Effectiveness of Blinding survey outcomes
timeFrame: 1 day
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital Emergency Department
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: David Barbic, MD MSc FRCPC,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbic D, Andolfatto G, Grunau B, Scheuermeyer FX, MacEwan W, Honer WG, Wong H, Barbic SP. Rapid agitation control with ketamine in the emergency department (RACKED): a randomized controlled trial protocol. Trials. 2018 Nov 26;19(1):651. doi: 10.1186/s13063-018-2992-x.