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

Table 1 Schedule of events

	Visit type
	Screening and treatment visit	Follow-up visit^a
Procedures:	Day 1	Day 3 (± 1 day)
Assessment of eligibility	X
Randomization	X
Study drug administration	X
Vital signs^b	X
Complete physical exam	X
Routine laboratory testing^c	X
ECG	X
RASS^b	X
Time to sedation	X
Time to psychiatric assessment (in the ED)	X
Rescue medication assessment^b	X
Incidence of sedation outcomes	X
Use of physical restraints	X
Effectiveness of Study Drug Blinding Survey	X
Study Nurse Experience Survey	X
Participant Experience Survey	X
VAS	X
Barnes Akathisia Scale	X
GDS	X
Pre-hospital use of force	X
Adverse event collection	X	X
Neuroleptic malignant syndrome	X^d	X
Review participant information sheet	X

^aVia telephone or in-person
^bConducted immediately after study medication administration and every 5 min until 30 min, after study medication administration
^cCBC, rapid metabolic panel, toxicology screen
^dAssessed within 24 h following study medication administration

ISSN: 1745-6215