Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward

• Status: Completed
• Trial end date: 2016-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Nacional de Rosario
• Treatments: Ketamine; Olanzapine

Criteria

Inclusion Criteria:

• signs of agitation,

• age between 18 and 64 years,

• bipolar (maniac or mixed episode)

• psychotic disorder diagnosis

• disorders due to drug abuse,

• organic disorder,

• anxiety or personality disorder

• Overt Agitation Severity Scale Total Score (OASS) equal or greater than 20

• Overt Aggressive Scale (OAS) with four or more positive items.

Exclusion Criteria:

• failure to agree to participate in the study,

• incapability of completing all steps

• unstable clinical disease -

• pregnancy