CompletedPhase 2

Rapid Agitation Control With Ketamine in the Emergency Department

Canada81 participantsStarted 2018-05-29

Plain-language summary

Compare intramuscular (IM) ketamine to a combination of IM midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the emergency department with psychomotor agitation and violent behavior.

Who can participate

Age range

19 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 19 - 60 years inclusively;
. Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score \> +3).

Exclusion criteria

. Less than 19 years of age;
. Greater than 60 years of age;
. Previous participation in this study;
. Women suspected or known to be pregnant or breastfeeding;
. Previous known hypersensitivity, intolerance or allergy to ketamine, midazolam or haloperidol or their components.
. Subjects who are in comatose states or have CNS depression due to alcohol or are taking other depressant drugs.
. Subjects with severe depressive states, spastic diseases and in Parkinson's syndrome, except in the case of dyskinesias due to levodopa treatment.
. Senile patients with pre-existing Parkinson-like symptoms.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.

Timeframe: 1 day

Trial details

NCT IDNCT03375671

SponsorDavid Barbic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-12

View on ClinicalTrials.gov More Violent Aggressive Behavior trials