Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital
Information source: Minneapolis Medical Research Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Agitation
Intervention: Ketamine (Drug); Haloperidol (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Jon B Cole
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.
Clinical Details
Official title: A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.
Secondary outcome: Number of participants intubated.venous pH serum potassium Total time the participant is a patient in the Emergency Department. Number of patients admitted versus number of patients discharged. venous lactate Number of patients experiencing laryngospasm. Number of patients experiencing dystonia.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 2014
Last updated: April 1, 2014
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