Rapid Agitation Control With Ketamine in the Emergency Department
- Conditions
- Violent Aggressive BehaviorKetamine
- Interventions
- Registration Number
- NCT03375671
- Lead Sponsor
- David Barbic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- Age 19 - 60 years inclusively;
- Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score > +3).
- 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.
- Subjects with a history of cerebrovascular accident
- Subjects in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension
- Subjects with severe cardiac decompensation
- Subjects who intend to have surgery of the pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used
- Subjects with acute pulmonary insufficiency
- Subjects with severe chronic obstructive pulmonary disease
- Subjects with acute narrow angle glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Midazolam + haloperidol Haloperidol Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM) Midazolam + haloperidol Midazolam injection Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM) Ketamine Ketalar Single administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM
- Primary Outcome Measures
Name Time Method Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1. 1 day Measured using Richmond Agitation Sedation Scale (RASS) in each arm
- Secondary Outcome Measures
Name Time Method Participant experience survey outcomes. 1 day measured using Participant Experience Survey
Study Nurse Experience survey outcomes. 1 day measured using Study Nurse Experience Survey
Percentage participants with adverse events in each arm up to 4 days measured by AE collection in each arm
Effectiveness of Blinding survey outcomes 1 day measured using Effectiveness of Study Drug Blinding Survey
Percentage of participants in each arm requiring rescue medications between 5 and 30 minutes (at 5 minutes interval) after study medication(s) administration by count. 1 day measured by rescue medication administration
Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm. 1 day measured by occurrence of neuroleptic malignant syndrome
Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria 1 day measured using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) criteria
Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint. 1 day measured by police account at study enrollment
Trial Locations
- Locations (1)
St. Paul's Hospital Emergency Department
🇨🇦Vancouver, British Columbia, Canada