Rapid Agitation Control With Ketamine in the Emergency Department

Ketamine

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.

Intervention / Treatment

  • Ketalar (DRUG)
    single administration of 5 mg/kg, IM
  • Midazolam injection (DRUG)
    single administration of 5 mg, IM
  • Haloperidol (DRUG)
    single administration of 5 mg, IM

Condition or Disease

  • Violent Aggressive Behavior
  • Ketamine

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 19 Years to 60 Years
    Enrollment: 81 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 29, 2018 ACTUAL
    Primary Completion: Mar 12, 2020 ACTUAL
    Completion Date: Mar 12, 2020 ACTUAL
    Study First Posted: Dec 18, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 26, 2020

    Sponsors / Collaborators

    Lead Sponsor: David Barbic
    Responsible Party: David Barbic

    Location

    Vancouver, British Columbia, Canada

    Participant Groups

    • 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)

    Eligibility Criteria

    Sex: All
    Minimum Age: 19
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

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

    Secondary Outcomes

    • measured by AE collection in each arm

    • measured by rescue medication administration

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

    • measured by occurrence of neuroleptic malignant syndrome

    • measured by police account at study enrollment

    • measured using Participant Experience Survey

    • measured using Study Nurse Experience Survey

    • measured using Effectiveness of Study Drug Blinding Survey

    More Details

    NCT Number: NCT03375671
    Acronym: RACKED
    Other IDs: H17-00571
    Study URL: https://clinicaltrials.gov/study/NCT03375671
    Last updated: Sep 29, 2023