RACKED: Rapid Agitation Control With Ketamine in the Emergency Department

Sponsor

David Barbic (Other)

Overall Status

Completed

CT.gov ID

NCT03375671

Collaborator

St Paul's Emergency Department Research Fund (Other), Centre for Health Evaluation and Outcome Sciences (CHÉOS) (Other)

Enrollment

Location

Arms

21.5

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Violent Aggressive Behavior Ketamine	Drug: Ketalar Drug: Midazolam injection Drug: Haloperidol	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Rapid Agitation Control With Ketamine in the Emergency Department (RACKED): a Randomized Controlled Trial

Actual Study Start Date :

May 29, 2018

Actual Primary Completion Date :

Mar 12, 2020

Actual Study Completion Date :

Mar 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine Single administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM	Drug: Ketalar single administration of 5 mg/kg, IM Other Names: ketamine
Active Comparator: Midazolam + haloperidol Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM)	Drug: Midazolam injection single administration of 5 mg, IM Drug: Haloperidol single administration of 5 mg, IM

Arm

Intervention/Treatment

Experimental: Ketamine

Single administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM

Drug: Ketalar

single administration of 5 mg/kg, IM

Other Names:

ketamine

Active Comparator: Midazolam + haloperidol

Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM)

Drug: Midazolam injection

single administration of 5 mg, IM

Drug: Haloperidol

single administration of 5 mg, IM

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Percentage participants with adverse events in each arm [up to 4 days]
measured by AE collection in each arm
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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 19 - 60 years inclusively;
Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score > +3).

Exclusion Criteria:

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