CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 314 enrolled
Drug / intervention
Ketamine-based protocol +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03554915
NCT03554915N/ACompleted

Ketamine Versus Midazolam for Prehospital Agitation

Hennepin Healthcare Research Institute·observational·Posted Jun 13, 2018·Updated Apr 5, 2019

In Brief

An observational study evaluating Ketamine-based protocol and Midazolam-based protocol for Agitation. Completed, enrolled 314 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 13, 2018
Enrollment StartAug 1, 2017
Primary CompletionJun 25, 2018
Study CompletionSep 24, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.1 years ago

Interventions

Ketamine-based protocolother

For profoundly agitated (physically violent) patients, intramuscular ketamine 5 mg/kg will be administered first line. For severely agitated patients, intramuscular ketamine 3 mg/kg will be administered first line.

Midazolam-based protocolother

For profoundly agitated patients, intramuscular midazolam 15 mg will be administered. For severely agitated patients, intramuscular midazolam 5 mg will be administered.