Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

NCT02103881 | Withdrawn Phase 4

• 1 other identifier: HSR #13-3682
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Agitation

Keywords

Agitation; Ketamine; Haloperidol; Emergency Medical Services; Feeling of restlessness; Increased motor activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of participants intubated.

  2 hours

• venous pH

  at one minutes and ten minutes post sedation

• serum potassium

  at one minute and ten minutes post sedation

• Total time the participant is a patient in the Emergency Department.

  2 hours

• Number of patients admitted versus number of patients discharged.

  2 hours

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Haloperidol

EXPERIMENTAL

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

Interventions

Ketamine DRUG

500 mg of intramuscular ketamine for severe pre-hospital agitation

Also known as: Ketalar

Ketamine

Haloperidol DRUG

Haloperidol 10 mg intramuscular for severe prehospital agitation.

Also known as: Haldol

Haloperidol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of severe agitation in the prehospital environment

You may not qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Ketamine; Haloperidol

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Butyrophenones; Ketones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 24, 2017

Record last verified: 2017-07