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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Rapid agitation control with ketamine in the emergency department (RACKED): a randomized controlled trial protocol

Authors: David Barbic, Gary Andolfatto, Brian Grunau, Frank X. Scheuermeyer, William MacEwan, William G. Honer, Hubert Wong, Skye P. Barbic

Published in: Trials | Issue 1/2018

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Abstract

Background

The rapid control of patients presenting to the emergency department (ED) with psychomotor agitation and violent behavior is paramount for the safety of patients and ED staff. The use of intramuscular (IM) ketamine in the pre-hospital and ED settings has demonstrated promising preliminary results to provide rapid and safe behavioral control. A prospective, randomized controlled trial is required to measure the potential superiority of IM ketamine compared to current standard care (IM benzodiazepines plus antipsychotics).

Methods

This will be a parallel, prospective, randomized, controlled trial of 5 mg/kg IM ketamine compared to a combination of 5 mg IM midazolam and 5 mg IM haloperidol. The study will enroll approximately 184 patients, randomized equally to two study arms. There will be one study visit during which study medication will be administered and assessments will be completed. A follow-up safety visit will occur on day 3. The primary objective of this study is to compare 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 ED with psychomotor agitation and violent behavior, as measured by the Richmond Agitation-Sedation Scale (RASS).

Discussion

We present a novel study to determine whether ketamine is a rapid and safe option, compared to a combination of midazolam and haloperidol for the sedation of patients presenting to the ED with psychomotor agitation and violent behavior. To our knowledge, this study is the first randomized controlled trial to compare ketamine to current standard care for this indication. We have attempted to address numerous logistical issues with the design of this study including a waiver of consent, ensuring adequate blinding of outcome assessors, patient enrolment, and data monitoring.

Trial registration

Clinicaltrials.gov, NCT03375671. Registered on 18 December 2017.
Appendix
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Metadata
Title
Rapid agitation control with ketamine in the emergency department (RACKED): a randomized controlled trial protocol
Authors
David Barbic
Gary Andolfatto
Brian Grunau
Frank X. Scheuermeyer
William MacEwan
William G. Honer
Hubert Wong
Skye P. Barbic
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2992-x

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