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| Name | Class |
|---|---|
| St Paul's Emergency Department Research Fund | UNKNOWN |
| Centre for Health Evaluation and Outcome Sciences (CHÉOS) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Single administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM |
|
| Midazolam + haloperidol | Active Comparator | Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketalar | Drug | single administration of 5 mg/kg, IM |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage participants with adverse events in each arm | measured by AE collection in each arm | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Barbic, MD MSc FRCPC, | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital Emergency Department | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30477544 | Derived | 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. |
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| ID | Term |
|---|---|
| D000374 | Aggression |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008874 | Midazolam |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Midazolam injection | Drug | single administration of 5 mg, IM |
|
| Haloperidol | Drug | single administration of 5 mg, IM |
|
measured by rescue medication administration |
| 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 | 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 | 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 | 1 day |
| Participant experience survey outcomes. | measured using Participant Experience Survey | 1 day |
| Study Nurse Experience survey outcomes. | measured using Study Nurse Experience Survey | 1 day |
| Effectiveness of Blinding survey outcomes | measured using Effectiveness of Study Drug Blinding Survey | 1 day |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002090 | Butyrophenones |
| D007659 | Ketones |