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

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

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.

Keywords: Agitation; Emergency medicine; Haloperidol; Ketamine; Midazolam; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this study has been obtained from the University of British Columbia, Providence Health Care Research Institute Research Ethics Board (H17–00571).

Consent for publication

All authors have given consent for publication. Consent for publication from patients is not applicable as this is a protocol.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT Flow Diagram of schedule of enrolment, interventions, and assessments

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