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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
81
single administration of 5 mg/kg, IM
single administration of 5 mg, IM
single administration of 5 mg, IM
St. Paul's Hospital Emergency Department
Vancouver, British Columbia, Canada
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
Time frame: 1 day
Percentage participants with adverse events in each arm
measured by AE collection in each arm
Time frame: 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.
measured by rescue medication administration
Time frame: 1 day
Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria
measured using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) criteria
Time frame: 1 day
Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.
measured by occurrence of neuroleptic malignant syndrome
Time frame: 1 day
Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint.
measured by police account at study enrollment
Time frame: 1 day
Participant experience survey outcomes.
measured using Participant Experience Survey
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Nurse Experience survey outcomes.
measured using Study Nurse Experience Survey
Time frame: 1 day
Effectiveness of Blinding survey outcomes
measured using Effectiveness of Study Drug Blinding Survey
Time frame: 1 day