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

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ClinicalTrials.gov Identifier: NCT03375671
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
St Paul's Emergency Department Research Fund
Centre for Health Evaluation and Outcome Sciences (CHÉOS)
Information provided by (Responsible Party):
David Barbic, University of British Columbia

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 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
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1. [ Time Frame: 1 day ]
    Measured using Richmond Agitation Sedation Scale (RASS) in each arm


Secondary Outcome Measures :
  1. Percentage participants with adverse events in each arm [ Time Frame: up to 4 days ]
    measured by AE collection in each arm

  2. 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. [ Time Frame: 1 day ]
    measured by rescue medication administration

  3. Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria [ Time Frame: 1 day ]
    measured using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) criteria

  4. Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm. [ Time Frame: 1 day ]
    measured by occurrence of neuroleptic malignant syndrome

  5. Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint. [ Time Frame: 1 day ]
    measured by police account at study enrollment

  6. Participant experience survey outcomes. [ Time Frame: 1 day ]
    measured using Participant Experience Survey

  7. Study Nurse Experience survey outcomes. [ Time Frame: 1 day ]
    measured using Study Nurse Experience Survey

  8. Effectiveness of Blinding survey outcomes [ Time Frame: 1 day ]
    measured using Effectiveness of Study Drug Blinding Survey



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375671


Contacts
Contact: Leslie Love 604-682-2344 ext 64242 llove@cheos.ubc.ca
Contact: David Barbic, MD MSc FRCPC 604-806-8480 david.barbic@ubc.ca

Locations
Canada, British Columbia
St. Paul's Hospital Emergency Department Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: David Barbic    604-806-8480    david.barbic@ubc.ca   
Principal Investigator: David Barbic, MD MSc FRCPC         
Sponsors and Collaborators
David Barbic
St Paul's Emergency Department Research Fund
Centre for Health Evaluation and Outcome Sciences (CHÉOS)
Investigators
Principal Investigator: David Barbic, MD MSc FRCPC, University of British Columbia

Responsible Party: David Barbic, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03375671     History of Changes
Other Study ID Numbers: H17-00571
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by David Barbic, University of British Columbia:
ketamine
aggressive behaviour
midazolam
haloperidol
emergency department

Additional relevant MeSH terms:
Emergencies
Aggression
Disease Attributes
Pathologic Processes
Behavioral Symptoms
Ketamine
Midazolam
Haloperidol
Haloperidol decanoate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Antiemetics