drugset / Trial / NCT03216941

Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward

NCT03216941

Phase 4 Completed 500 enrolled Universidad Nacional de Rosario
RandomizedParallel-groupSingle-blindTreatment

Summary

comparison of intramuscular olanzapine and ketamine efficacy as first medication for fast sedation of patients with agitation and aggressive behavior. Five hundred patients with agitation caused by psychiatric disorder were randomly assigned under double-blind conditions to receive olanzapine or ketiapine. The Overt Agitation Severity Scale, Overt Aggression Scale and Ramsay Sedation Scale will be applied within 12 hours after the first dosage.

Timeline

Start
2015-01-01
Primary completion
2016-01-01
Completion
2016-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 10 mg Intramuscular
Comparator Olanzapine Small molecule 10 mg Intramuscular

Indications