Violent Aggressive BehaviorPhase 2RACKEDNCT03375671
Rapid Agitation Control With Ketamine in the Emergency Department
A Phase 2 study testing Ketalar, Midazolam injection and Haloperidol in people with Violent Aggressive Behavior and Ketamine, run by David Barbic at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Violent Aggressive Behavior, Ketamine
- What is being tested?
- Ketalar, Midazolam injection and Haloperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2018to 12 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 19 - 60 years inclusively;
- Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score > +3).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Paul's Hospital Emergency Department
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Rapid Agitation Control With Ketamine in the Emergency Department (RACKED): a Randomized Controlled Trial
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.
- Conditions
- Violent Aggressive Behavior, Ketamine
- Being tested
- Ketalar, Midazolam injection, Haloperidol
- Keywords
- ketamine, aggressive behaviour, midazolam, haloperidol, emergency department
- Medical subject headings
- Aggression, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetalarDrug
Also called ketamine
single administration of 5 mg/kg, IM
Midazolam injectionDrug
single administration of 5 mg, IM
HaloperidolDrug
single administration of 5 mg, IM
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Single administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM Receives: Drug: Ketalar |
| Midazolam + haloperidol | Active comparator | Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM) Receives: Drug: Midazolam injection; Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.
Measured using Richmond Agitation Sedation Scale (RASS) in each arm
Measured: 1 day
Secondary outcomes (8)
Percentage participants with adverse events in each arm
measured by AE collection in each arm
Measured: up to 4 days
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.
measured by rescue medication administration
Measured: 1 day
Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria
measured using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS) criteria
Measured: 1 day
Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.
measured by occurrence of neuroleptic malignant syndrome
Measured: 1 day
Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint.
measured by police account at study enrollment
Measured: 1 day
Participant experience survey outcomes.
measured using Participant Experience Survey
Measured: 1 day
Study Nurse Experience survey outcomes.
measured using Study Nurse Experience Survey
Measured: 1 day
Effectiveness of Blinding survey outcomes
measured using Effectiveness of Study Drug Blinding Survey
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start29 May 2018
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Violent Aggressive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Barbic
- Sponsor type
- University, hospital or other
- Collaborators
- St Paul's Emergency Department Research Fund, Centre for Health Evaluation and Outcome Sciences (CHÉOS)
- Responsible party
- Sponsor-investigator, David Barbic, University of British Columbia
- Investigators
- David Barbic, MD MSc FRCPC,, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375671
- Sponsor's protocol ID
- H17-00571
- Acronym
- RACKED
- Status last verified
- Nov 2020
- First submitted
- 12 Dec 2017
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barbic D, Andolfatto G, Grunau B, Scheuermeyer FX, MacEwan W, Honer WG, Wong H, Barbic SP. Rapid agitation control with ketamine in the emergency department (RACKED): a randomized controlled trial protocol. Trials. 2018 Nov 26;19(1):651. doi: 10.1186/s13063-018-2992-x.
PubMed 30477544
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Agitation Control With Ketamine in the Emergency Department (RACKED): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03375671
- Acronym / sponsor ID
- RACKED / H17-00571
- Conditions
- Violent Aggressive Behavior, Ketamine
- Keywords
- ketamine, aggressive behaviour, midazolam, haloperidol, emergency department
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- David BarbicUniversity, hospital or other
- Collaborators
- St Paul's Emergency Department Research Fund, Centre for Health Evaluation and Outcome Sciences (CHÉOS)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetalarSingle administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM |
| Midazolam + haloperidol | Active comparator | Drug: Midazolam injection, Drug: HaloperidolSingle administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 19 - 60 years inclusively;
- Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score > +3).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetalarAlso: ketaminesingle administration of 5 mg/kg, IM | Drug | Ketamine |
| Midazolam injectionsingle administration of 5 mg, IM | Drug | Midazolam + haloperidol |
| Haloperidolsingle administration of 5 mg, IM | Drug | Midazolam + haloperidol |
Primary outcome
Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.
Time frame: 1 day
Measured using Richmond Agitation Sedation Scale (RASS) in each arm
8 secondary outcomes
Percentage participants with adverse events in each arm
Time frame: up to 4 days
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.
Time frame: 1 day
Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria
Time frame: 1 day
Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.
Time frame: 1 day
Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint.
Time frame: 1 day
Participant experience survey outcomes.
Time frame: 1 day
Study Nurse Experience survey outcomes.
Time frame: 1 day
Effectiveness of Blinding survey outcomes
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Derived from this study: PubMed 30477544Barbic D, Andolfatto G, Grunau B, Scheuermeyer FX, MacEwan W, Honer WG, Wong H, Barbic SP. Rapid agitation control with ketamine in the emergency department (RACKED): a randomized controlled trial protocol. Trials. 2018 Nov 26;19(1):651. doi: 10.1186/s13063-018-2992-x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Barbic, MD MSc FRCPC, principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketalar, Midazolam injection and Haloperidol in people with Violent Aggressive Behavior and Ketamine, run by David Barbic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.