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OpenTrials
Completed

NCT Number: NCT03375671

Rapid Agitation Control With Ketamine in the Emergency Department

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.

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Paul's Hospital Emergency Department

Vancouver, British Columbia, V6Z 1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketalar

Drug

single administration of 5 mg/kg, IM

Other names: ketamine

Midazolam injection

Drug

single administration of 5 mg, IM

Haloperidol

Drug

single administration of 5 mg, IM

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

David Barbic

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RACKED

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2017
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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