Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward
Launched by UNIVERSIDAD NACIONAL DE ROSARIO · Jul 11, 2017
Trial Information
Current as of July 09, 2025
Completed
Keywords
ClinConnect Summary
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) equa...
Gender
ALL
Eligibility 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
About Universidad Nacional De Rosario
The Universidad Nacional de Rosario (UNR) is a prestigious academic institution in Argentina, recognized for its commitment to research and innovation in various fields, including medical and health sciences. With a strong focus on advancing clinical knowledge and improving patient care, UNR sponsors clinical trials that leverage its extensive network of researchers, healthcare professionals, and state-of-the-art facilities. The university is dedicated to adhering to the highest ethical standards and regulatory guidelines, ensuring that all trials contribute valuable insights to the scientific community while prioritizing participant safety and well-being. Through its collaborative approach, UNR aims to foster advancements in healthcare that benefit both local and global populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Miguel, Buenos Aires, Argentina
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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