Rapid Agitation Control With Ketamine in the Emergency Department

NCT03375671 | Completed Phase 2

• 1 other identifier: H17-00571
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Violent Aggressive Behavior; Ketamine

Keywords

ketamine; aggressive behaviour; midazolam; haloperidol; emergency department

Outcome Measures

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

  1 day

Secondary Outcomes (8)

• Percentage participants with adverse events in each arm

  up to 4 days

• 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.

  1 day

• Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria

  1 day

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

  1 day

• Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint.

  1 day

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Drug: Ketalar

Midazolam + haloperidol

ACTIVE COMPARATOR

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

Drug: Midazolam injection; Drug: Haloperidol

Interventions

Ketalar DRUG

single administration of 5 mg/kg, IM

Also known as: ketamine

Ketamine

Midazolam injection DRUG

single administration of 5 mg, IM

Midazolam + haloperidol

Haloperidol DRUG

single administration of 5 mg, IM

Midazolam + haloperidol

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 19 - 60 years inclusively;
• Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score \> +3).

You may not qualify if:

• 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

Sponsors & Collaborators

• David Barbic: lead
• St Paul's Emergency Department Research Fund: collaborator
• Centre for Health Evaluation and Outcome Sciences (CHÉOS): collaborator

Study Sites (1)

St. Paul's Hospital Emergency Department

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

• 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.

  PMID: 30477544 DERIVED

MeSH Terms

Conditions

Aggression; Emergencies

Interventions

Ketamine; Midazolam; Haloperidol

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones

Study Officials

• David Barbic, MD MSc FRCPC,

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: May 29, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CA (1)