Back to results

Rapid Agitation Control With Ketamine in the Emergency Department (RACKED)

Primary Purpose

Violent Aggressive Behavior, Ketamine

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Ketalar

Midazolam injection

Haloperidol

About this trial

This is an interventional treatment trial for Violent Aggressive Behavior focused on measuring ketamine, aggressive behaviour, midazolam, haloperidol, emergency department

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

St. Paul's Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine

Midazolam + haloperidol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage participants with adverse events in each arm

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.

measured by rescue medication administration

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

Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.

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.

measured by police account at study enrollment

Participant experience survey outcomes.

measured using Participant Experience Survey

Study Nurse Experience survey outcomes.

measured using Study Nurse Experience Survey

Effectiveness of Blinding survey outcomes

measured using Effectiveness of Study Drug Blinding Survey

Full Information

NCT ID

NCT03375671

First Posted

December 12, 2017

Last Updated

November 26, 2020

Sponsor

David Barbic

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03375671

Brief Title

Rapid Agitation Control With Ketamine in the Emergency Department

Acronym

RACKED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

May 29, 2018 (Actual)

Primary Completion Date

March 12, 2020 (Actual)

Study Completion Date

March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David Barbic

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Violent Aggressive Behavior, Ketamine

Keywords

ketamine, aggressive behaviour, midazolam, haloperidol, emergency department

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Experimental

Arm Description

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

Arm Title

Midazolam + haloperidol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ketalar

Other Intervention Name(s)

ketamine

Intervention Description

single administration of 5 mg/kg, IM

Intervention Type

Drug

Intervention Name(s)

Midazolam injection

Intervention Description

single administration of 5 mg, IM

Intervention Type

Drug

Intervention Name(s)

Haloperidol

Intervention Description

single administration of 5 mg, IM

Primary Outcome Measure Information:

Title

Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.

Description

Measured using Richmond Agitation Sedation Scale (RASS) in each arm

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Percentage participants with adverse events in each arm

Description

measured by AE collection in each arm

Time Frame

up to 4 days

Title

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.

Description

measured by rescue medication administration

Time Frame

1 day

Title

Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria

Description

measured using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) criteria

Time Frame

1 day

Title

Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.

Description

measured by occurrence of neuroleptic malignant syndrome

Time Frame

1 day

Title

Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint.

Description

measured by police account at study enrollment

Time Frame

1 day

Title

Participant experience survey outcomes.

Description

measured using Participant Experience Survey

Time Frame

1 day

Title

Study Nurse Experience survey outcomes.

Description

measured using Study Nurse Experience Survey

Time Frame

1 day

Title

Effectiveness of Blinding survey outcomes

Description

measured using Effectiveness of Study Drug Blinding Survey

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Barbic, MD MSc FRCPC,

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Paul's Hospital Emergency Department

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30477544

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.

Results Reference

derived

Learn more about this trial

Rapid Agitation Control With Ketamine in the Emergency Department

We'll reach out to this number within 24 hrs