Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02103881
• Other study ID #: HSR #13-3682
• Status: Withdrawn
• Phase: Phase 4
• First received: February 20, 2014
• Last updated: July 20, 2017
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: July 2017
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

Intervention

Drug:
• Ketamine
500 mg of intramuscular ketamine for severe pre-hospital agitation
• Haloperidol
Haloperidol 10 mg intramuscular for severe prehospital agitation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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