Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward

NCT03216941 | Completed Phase 4 DMC

• 1 other identifier: msm1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychomotor Agitation; Psychiatric Disorder; Emergency Psychiatric; Tranquilizers

Keywords

Psychomotor agitation; Tranquilizing agents

Outcome Measures

Primary Outcomes (1)

• sedation status

  subjects will be assessed 1 hour, 2 hours, 4 hours, 6 hours and 12 hours after administration of the medication with Ramsay Sedation Scale score (RSS).

  1 to 12 hours

Secondary Outcomes (1)

• adverse effects

  1 to 24 hours

Study Arms (2)

ketamine

ACTIVE COMPARATOR

assessment of agitation status with Ramsay Sedation Scale administration of ketamine 10 mg / ml IM one dose supervision of vital signs registration of time of ketamine administration registration of time when expected outcome is obtained follow up of vital signs supervision until obsevation period expires (12 hours after admission to emergency board) registration of adverse effects registration if other interventions were applied (aside of ketamine administration) withdrawal of patient from the study if other medication was needed (aside of ketamine)

Drug: Ketamine

olanzapine

ACTIVE COMPARATOR

assessment of agitation status with Ramsay Sedation Scale administration of olanzapine 10 mg / ml IM one dose supervision of vital signs registration of time of olanzapine administration registration of time when expected outcome is obtained follow up of vital signs supervision until obsevation period expires (12 hours after admission to emergency board) registration of adverse effects registration if other interventions were applied (aside of olanzapine administration) withdrawal of patient from the study if other medication was needed (aside of olanzapine)

Drug: Ketamine

Interventions

Ketamine DRUG

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.

Also known as: olanzapine

ketamine; olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• failure to agree to participate in the study,
• incapability of completing all steps
• unstable clinical disease -
• pregnancy

Sponsors & Collaborators

• Universidad Nacional de Rosario: lead

Study Sites (1)

hospital Larcade

San Miguel, Buenos Aires, 1405, Argentina

Location

MeSH Terms

Conditions

Psychomotor Agitation; Mental Disorders

Interventions

Ketamine; Olanzapine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: care provider were masked with regard to the patient's treatment assignment, and patients were instructed not to reveal their current treatment to the investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 31, 2016
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

AR (1)