Rapid Agitation Control With Ketamine in the Emergency Department

Ketamine Clinical Trial

— RACKED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375671
• Other study ID #: H17-00571
• Status: Completed
• Phase: Phase 2
• Start date: May 29, 2018
• Est. completion date: March 12, 2020

Study information

• Verified date: November 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Emergencies
• Ketamine
• Violent Aggressive Behavior

Intervention

Drug:
• Ketalar
single administration of 5 mg/kg, IM
• Midazolam injection
single administration of 5 mg, IM
• Haloperidol
single administration of 5 mg, IM

Locations

Country	Name	City	State
Canada	St. Paul's Hospital Emergency Department	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
David Barbic	Centre for Health Evaluation and Outcome Sciences (CHÉOS), St Paul's Emergency Department Research Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	Percentage participants with adverse events in each arm	measured by AE collection in each arm	up to 4 days
Secondary	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	1 day
Secondary	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	1 day
Secondary	Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.	measured by occurrence of neuroleptic malignant syndrome	1 day
Secondary	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	1 day
Secondary	Participant experience survey outcomes.	measured using Participant Experience Survey	1 day
Secondary	Study Nurse Experience survey outcomes.	measured using Study Nurse Experience Survey	1 day
Secondary	Effectiveness of Blinding survey outcomes	measured using Effectiveness of Study Drug Blinding Survey	1 day