Agitation
Conditions
Keywords
Agitation, Ketamine, Haloperidol, Emergency Medical Services, Feeling of restlessness, Increased motor activity
Brief summary
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.
Interventions
DRUGKetamine
500 mg of intramuscular ketamine for severe pre-hospital agitation
DRUGHaloperidol
Haloperidol 10 mg intramuscular for severe prehospital agitation.
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of severe agitation in the prehospital environment
Exclusion criteria
* Prisoners * Persons known to be younger than 18 years old * Persons suspected to be younger than 18 years old * Obviously gravid women * Persons with profound agitation * Persons who are unable to be transported to the treating facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS. | 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| venous pH | at one minutes and ten minutes post sedation | 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. |
| serum potassium | at one minute and ten minutes post sedation | 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. |
| Total time the participant is a patient in the Emergency Department. | 2 hours | 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. |
| Number of participants intubated. | 2 hours | 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. |
| venous lactate | at one minute and ten minutes post sedation | 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. |
| Number of patients experiencing laryngospasm. | 2 hours | 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. |
| Number of patients experiencing dystonia. | 2 hours | 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. |
| Number of patients admitted versus number of patients discharged. | 2 hours | 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. |
Outcome results
None listed