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Trials. 2018 Nov 26;19(1):651. doi: 10.1186/s13063-018-2992-x.

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

Author information

1
Department of Emergency Medicine, St Paul's Hospital, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada. David.barbic@ubc.ca.
2
Centre for Health Evaluation Outcome Sciences, Vancouver, BC, Canada. David.barbic@ubc.ca.
3
Department of Emergency Medicine, Lion's Gate Hospital, 231 15th St E, North Vancouver, BC, Canada.
4
Department of Emergency Medicine, St Paul's Hospital, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.
5
Centre for Health Evaluation Outcome Sciences, Vancouver, BC, Canada.
6
Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.
7
School of Public Health and Epidemiology, University of British Columbia, Vancouver, BC, Canada.
8
Department of Occupational Science and Occupational Therapy, Vancouver, BC, Canada.

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

PMID:
30477544
PMCID:
PMC6258312
DOI:
10.1186/s13063-018-2992-x
[Indexed for MEDLINE]
Free PMC Article

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