Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Study Overview
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Brief Summary
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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.

Official Title
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A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation

Conditions
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Agitation

Intervention / Treatment
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* Drug: Ketamine
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Patients enrolled in this arm will be given 500 mg of intramuscular ketamine for their severe agitation they experience in the prehospital environment. | Drug: Ketamine<br>* 500 mg of intramuscular ketamine for severe pre-hospital agitation<br>* Other names: Ketalar;|
| Experimental: Haloperidol<br>Patients enrolled in this arm will be given 10 mg of intramuscular haloperidol for their severe agitation they experience in the prehospital environment. | Drug: Haloperidol<br>* Haloperidol 10 mg intramuscular for severe prehospital agitation.<br>* Other names: Haldol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agitation, Ketamine, Haloperidol, Emergency Medical Services, Feeling of restlessness, Increased motor activity