This research study is being done to find out if one of two drugs, ketamine or haloperidol, is better for treating agitation. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness is involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine is superior to haloperidol for treatment of agitation in the prehospital environment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
500 mg of intramuscular ketamine for severe pre-hospital agitation
Haloperidol 10 mg intramuscular for severe prehospital agitation.
Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.
The Altered Mental Status Scale (AMSS) is an integral ordinal scale evaluating both agitation and sedation with scores from -4 to +4. It was developed at our institution and has been internally and externally validated. This scale is a modified version of the Behavioral Activity Rating Scale with additional data points from the Observer's Assessment of Alertness Scale. Effectiveness of sedation will be defined as an AMS score less than or equal to 0. AMSS will be determined by the treating paramedic, who will undergo training as a research associate prior to commencement of the study. Participants will be followed for the duration of agitation, an expected average of 2 hours.
Time frame: 2 hours
Number of participants intubated.
Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if the patient is intubated.
Time frame: 2 hours
venous pH
Venous blood will be drawn at one and ten minutes post sedation and assessed using point-of-care testing for pH. Enrolling paramedics or research associates in the Emergency Department will record the data.
Time frame: at one minutes and ten minutes post sedation
serum potassium
Venous blood will be drawn at one and ten minutes post sedation and assessed using point-of-care testing for potassium concentration. Enrolling paramedics or research associates in the Emergency Department will record the data.
Time frame: at one minute and ten minutes post sedation
Total time the participant is a patient in the Emergency Department.
Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record both the time the patient arrives in the Emergency Department, and when they leave the Emergency Department.
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Time frame: 2 hours
Number of patients admitted versus number of patients discharged.
Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if the patient is admitted or discharged.
Time frame: 2 hours
venous lactate
Venous blood will be drawn at one and ten minutes post sedation and assessed using point-of-care testing for lactate concentration. Enrolling paramedics or research associates in the Emergency Department will record the data.
Time frame: at one minute and ten minutes post sedation
Number of patients experiencing laryngospasm.
Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if laryngospasm occurs.
Time frame: 2 hours
Number of patients experiencing dystonia.
Participants will be followed for the duration of agitation, an expected average of 2 hours.Enrolling paramedics or research associates in the Emergency Department will record if dystonia occurs.
Time frame: 2 hours