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NCT03554915 · ClinicalTrials.gov registry record
Ketamine Versus Midazolam for Prehospital Agitation
A clinical trial, sponsored by Hennepin Healthcare Research Institute.
- Completed
- Registry status
- 314
- Enrollment target
NCT03554915: Completed study, sponsored by Hennepin Healthcare Research Institute.
NCT03554915 is a clinical trial that has completed, run by Hennepin Healthcare Research Institute. The registered enrollment target is 314 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03554915 has completed, sponsored by Hennepin Healthcare Research Institute.
- COMPLETED
- Registry status
- 314 participants
- Enrollment target
Study Summary
This research study is being done to figure out the best approach to treatment of pre-hospital agitation. It will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam-based. 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 are 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 a ketamine-based protocol will achieve a faster time to adequate sedation than a midazolam-based protocol for treatment of agitation in the prehospital environment. This study will observe the natural history of an emergency medical services standard operating procedure change from a ketamine-based protocol to a midazolam-based protocol.
Primary Outcome
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 AMSS score less than or equal to +1. AMSS will be determined by the treating pa
Interventions
- OTHER Ketamine-based protocol
- OTHER Midazolam-based protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2018-09-24 |
What the finished NCT03554915 record still lists
NCT03554915 is an observational study that tracks outcomes without assigning an intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Ketamine-based protocol is the first listed.
NCT03554915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03554915 about?
NCT03554915 is a clinical study titled "Ketamine Versus Midazolam for Prehospital Agitation". This research study is being done to figure out the best approach to treatment of pre-hospital agitation. It will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam-based. Agitation is a state of extreme emotional disturbance where patients can become physically aggr...
What is the current status of trial NCT03554915?
This trial is currently completed. The enrollment target is 314 participants. The study started on 2017-08-01. Estimated completion is 2018-09-24.
What interventions are being tested in trial NCT03554915?
The interventions under investigation include: Ketamine-based protocol (OTHER), Midazolam-based protocol (OTHER).
Who is sponsoring clinical trial NCT03554915?
This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.
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