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Rapid Agitation Control With Ketamine in the Emergency Department

NCT ID: NCT03375671

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2020-03-12

Brief Summary

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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

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Conditions

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Violent Aggressive Behavior Ketamine

Keywords

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ketamine aggressive behaviour midazolam haloperidol emergency department

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ketamine

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

Group Type EXPERIMENTAL

Ketalar

Intervention Type DRUG

single administration of 5 mg/kg, IM

Midazolam + haloperidol

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

Group Type ACTIVE_COMPARATOR

Midazolam injection

Intervention Type DRUG

single administration of 5 mg, IM

Haloperidol

Intervention Type DRUG

single administration of 5 mg, IM

Interventions

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Ketalar

single administration of 5 mg/kg, IM

Intervention Type DRUG

Midazolam injection

single administration of 5 mg, IM

Intervention Type DRUG

Haloperidol

single administration of 5 mg, IM

Intervention Type DRUG

Other Intervention Names

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ketamine

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Paul's Emergency Department Research Fund

UNKNOWN

Sponsor Role collaborator

Centre for Health Evaluation and Outcome Sciences (CHÉOS)

UNKNOWN

Sponsor Role collaborator

David Barbic

OTHER

Sponsor Role lead

Responsible Party

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David Barbic

Clinical Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Barbic, MD MSc FRCPC,

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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St. Paul's Hospital Emergency Department

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30477544 (View on PubMed)

Other Identifiers

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H17-00571

Identifier Type: -

Identifier Source: org_study_id