Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward
Condition: Psychomotor Agitation; Psychiatric Disorder; Emergency Psychiatric; Tranquilizers
MeSH terms: Psychomotor Agitation; Emergencies; Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      double-blind controlled trial to compare effectiveness of intramuscular olanzapine and
      ketamine as first medication to fast sedation of patients with agitation caused by
      psychiatric conditions. Randomization will be performed by permuted blocks allocation in
      which ketiamine or olanzapine standard treatment will be assigned to blocks of five patients
      and distributed in this order: olanzapine and ketiamine. This assignment will be repeated
      until the total number of subjects (500) be reached.

      agitation status will be operationalized using Overt Agitation Severity Scale Total Score
      (OASS) equal or greater than 20 and Overt Aggressive Scale (OAS) with four or more positive
      items. Full physical and neurological examination will be completed as soon as possible,
      whenever patient is considered eligible for the study. Written Informed consent should be
      provided before and after participating in this study, and should be reviewed and approved by
      the institutional review board. Written consent obtained before admission to the emergency
      ward by legal guardian and after 12 hours by the patient (whenever he or she is is able to
      understand the information) or by the guardian. This study will comply with principles of the
      Declaration of Helsinki and Good Clinical Practice and approved by the Institutional Review
      Board (IRB) of Hospital Larcade of San Miguel County (Province of Buenos AIres (Project
      msm001) inter-rater reproducibility will be evaluated by two raters which will repeatedly
      apply OASS, OAS and RSS to patients admitted to the emergency room before the study until the
      intraclass correlation coefficient (ICC) reach a score of 0.80 or greater medications will be
      packaged in identical color-coded boxes and dosage of of olanzapine and ketiamine will be
      determined according to standard protocols and previous studies.

      If a subject needs another intervention will be removed from the study. subjects will be
      assessed from 1 to 12 hours after administration of selected medication.

      psychiatrists will be masked to patient's treatment assignment, and patients will be
      instructed not to reveal current treatment to investigators.

      clinical safety of treatment will be assessed by notification and with an close-ended inquiry
      into adverse events together with full physical examination and vital signs measurements.
      Statistical analyses mean and standard deviation (SD) and comparisons of baseline demographic
      and clinical characteristics with one-way analysis of variance (ANOVA), chi-square test for
      categorical variables and mixed-effect analyses of covariance (ANCOVAs) with medication
      (olanzapine, ketiamine) as between-groups factor and time (1 hour, 2 hours, 4 hours, 6 hours
      and 12 hours) as a within-group factor. OASS at time zero, OAS at time zero, and presence of
      excessive sedation will be fixe covariates, and symptom ratings (OASS, OAS and RSS) will be
      time-varying covariates.

      differences between groups at each time point and variance with post-hoc Duncan's tests will
      be calculated to compare mean OASS, OAS and RSS scores between groups.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): study medications were packaged in identical color-coded boxes. first dosage included either 10 mg of olanzapine, or 10 mg of ketamine Dosages were chosen based on previous studies After the initial dose, no additional dosis were allowed if supplemental medication eas needed according to clinician judgment the subject will be immediately removed from the study.
All subjects will be assessed 1 hour, 2 hours, 4 hours, 6 hours and 12 hours after t he first administration of the medication.
Other intervention name(s): olanzapine
Intervention MeSH terms: Ketamine; Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind controlled trial to compare the effectiveness of intramuscular olanzapine and ketamine as first medication(s) used to treat patients with agitation caused by psychosis.
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Psychomotor agitation; Tranquilizing agents