CompletedPhase 2ketamine

Rapid Agitation Control With Ketamine in the Emergency Department

Sponsored by David Barbic

NCT ID
NCT03375671
Target Enrollment
81 participants
Start Date
2018-05-29
Est. Completion
2020-03-12

About This Study

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 Studied

Violent Aggressive BehaviorKetamine

Interventions

  • Ketalar
  • Midazolam injection
  • Haloperidol

Eligibility

Age:19 Years - 60 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

1. Age 19 - 60 years inclusively;
2. Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score \> +3).

Exclusion Criteria:

1. Less than 19 years of age;
2. Greater than 60 years of age;
3. Previous participation in this study;
4. Women suspected or known to be pregnant or breastfeeding;
5. Previous known hypersensitivity, intolerance or allergy to ketamine, midazolam or haloperidol or their components.
6. Subjects who are in comatose states or have CNS depression due to alcohol or are taking other depressant drugs.
7. Subjects with severe depressive states, spastic diseases and in Parkinson's syndrome, except in the case of dyskinesias due to levodopa treatment.
8. Senile patients with pre-existing Parkinson-like symptoms.
9. Subjects with a history of cerebrovascular accident
10. Subjects in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension
11. Subjects with severe cardiac decompensation
12. Subjects who intend to have surgery of the pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used
13. Subjects with acute pulmonary insufficiency
14. Subjects with severe chronic obstructive pulmonary disease
15. Subjects with acute narrow angle glaucoma

Study Locations (1)

St. Paul's Hospital Emergency Department
Vancouver, British Columbia, Canada

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source