ClinicalTrials.gg
Sign In
CompletedNCT03375671RACKEDUpdated Nov 30, 2020

Rapid Agitation Control With Ketamine in the Emergency Department

A Phase 2 interventional study of Ketalar and Midazolam injection in Violent Aggressive Behavior and Ketamine, sponsored by David Barbic. Completed at 1 site in Canada. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by David Barbic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Violent Aggressive Behavior
  • Ketamine

Keywords

  • ketamine
  • aggressive behaviour
  • midazolam
  • haloperidol
  • emergency department
03

In context

Aggression

248 studies on the registry are indexed under Aggression; 41 are open to participants now.

This study's enrollment of 81 is close to the median of 80 across 221 interventional studies indexed under Aggression.

Browse Aggression studies →

Lead sponsor

This is the only study on the registry with David Barbic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , 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
  15. Subjects with acute narrow angle glaucoma
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Ketamine

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

    Drug: Ketalar

  • Active comparator
    Midazolam + haloperidol

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

    Drug: Midazolam injection · Drug: Haloperidol

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day

Secondary outcomes

  1. Percentage participants with adverse events in each arm

    measured by AE collection in each arm

    Time frame: up to 4 days

  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.

    measured by rescue medication administration

    Time frame: 1 day

  3. 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

    Time frame: 1 day

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

    measured by occurrence of neuroleptic malignant syndrome

    Time frame: 1 day

  5. 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

    Time frame: 1 day

  6. Participant experience survey outcomes.

    measured using Participant Experience Survey

    Time frame: 1 day

  7. Study Nurse Experience survey outcomes.

    measured using Study Nurse Experience Survey

    Time frame: 1 day

  8. Effectiveness of Blinding survey outcomes

    measured using Effectiveness of Study Drug Blinding Survey

    Time frame: 1 day

07

Study locations

1 site
  • St. Paul's Hospital Emergency Department
    Vancouver, British Columbia V6Z 1Y6, Canada
08

References and documents

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. PubMed 30477544 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Mar 2020, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2017
First posted
Dec 18, 2017
StartActual
May 29, 2018
Primary completionActual
Mar 12, 2020
CompletionActual
Mar 12, 2020
Last update
Nov 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03375671
Lead sponsor
David Barbic
Collaborators
St Paul's Emergency Department Research Fund, Centre for Health Evaluation and Outcome Sciences (CHÉOS)
Responsible party
David Barbic (Clinical Assistant Professor, University of British Columbia) — Sponsor-investigator
First posted
Dec 18, 2017
Start date
May 29, 2018
Primary completion
Mar 12, 2020
Completion
Mar 12, 2020
Last update
Nov 30, 2020

Study contacts

David Barbic, MD MSc FRCPC,
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ketamine

Other studies in this condition

Aggression →

Start the discussion