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

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ClinicalTrials.gov Identifier: NCT03375671
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : November 30, 2020
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

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 18, 2017
Last Update Posted Date November 30, 2020
Actual Study Start Date  ICMJE May 29, 2018
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • Percentage participants with adverse events in each arm [ Time Frame: 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. [ Time Frame: 1 day ]
    measured by rescue medication administration
  • 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
  • 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
  • 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
  • Participant experience survey outcomes. [ Time Frame: 1 day ]
    measured using Participant Experience Survey
  • Study Nurse Experience survey outcomes. [ Time Frame: 1 day ]
    measured using Study Nurse Experience Survey
  • Effectiveness of Blinding survey outcomes [ Time Frame: 1 day ]
    measured using Effectiveness of Study Drug Blinding Survey
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid Agitation Control With Ketamine in the Emergency Department
Official Title  ICMJE Rapid Agitation Control With Ketamine in the Emergency Department (RACKED): a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Violent Aggressive Behavior
  • Ketamine
Intervention  ICMJE
  • Drug: Ketalar
    single administration of 5 mg/kg, IM
    Other Name: ketamine
  • Drug: Midazolam injection
    single administration of 5 mg, IM
  • Drug: Haloperidol
    single administration of 5 mg, IM
Study Arms  ICMJE
  • Experimental: Ketamine
    Single administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM
    Intervention: Drug: Ketalar
  • Active Comparator: Midazolam + haloperidol
    Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM)
    Interventions:
    • Drug: Midazolam injection
    • Drug: Haloperidol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2020)
81
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2017)
184
Actual Study Completion Date  ICMJE March 12, 2020
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03375671
Other Study ID Numbers  ICMJE H17-00571
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party David Barbic, University of British Columbia
Study Sponsor  ICMJE David Barbic
Collaborators  ICMJE
  • St Paul's Emergency Department Research Fund
  • Centre for Health Evaluation and Outcome Sciences (CHÉOS)
Investigators  ICMJE
Principal Investigator: David Barbic, MD MSc FRCPC, University of British Columbia
PRS Account University of British Columbia
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP