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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
SLCTR/2011/013 |
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Date of registration:
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28/11/2011 |
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Primary sponsor: |
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Public title:
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Study on rapid tranquilization: comparison of intramuscular olanzapine and intramuscular haloperidol
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Scientific title:
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Rapid tranquillization of agitated or aggressive patients in an in-patient psychiatric setting: Pragmatic randomized double-blind trial of intramuscular olanzapine versus intramuscular haloperidol |
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Date of first enrolment:
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31/12/2011 |
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Target sample size:
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134 |
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Recruitment status: |
Pending |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={A6F5A277-151E-4361-BB9D-2BCC2ED74D23} |
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Study type:
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Interventional |
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Study design:
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Pragmatic, randomized double blind trial
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr Hiranya Wijesundara
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Address:
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Iddamaldeniya, Dompe
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Telephone:
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0773420532 |
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Email:
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hiranya.w@gmail.com |
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Affiliation:
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Senior Registrar in Psychiatry |
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Name:
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Dr Hiranya Wijesundara
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Address:
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University Psychiatry Unit, National Hospital, Sri Lanka
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Telephone:
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0773420532 |
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Email:
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hiranya.w@gmail.com |
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Affiliation:
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Senior Registrar in Psychiatry (Guarantor - Dr Varuni de Silva, Senior Lecturer, Department of Psychological Medicine, Faculty of Medicine, University of Colombo) |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 18-65 years
2. Patients admitted with acute agitation or already hospitalized and become agitated with a total score of Positive and Negative Symptoms Scale-Excited Component (PANSS-EC) >= 14 or at least one item with a score of >= 4
(If this requirement is not met at baseline and rapid tranquilization has not been given the patient could be re-evaluated in the subsequent 24 hours)
3. Clear indication of intramuscular route of administration according to the attending doctor because of agitation, aggression, or violent behaviour
4. Presence of good physical health confirmed by medical history and physical examination
Exclusion criteria: 1. Agitation primarily due to acute intoxication
2. History of drug or alcohol dependence in the previous 8 weeks
3. Use of benzodiazepines / other hypnotics/ oral or intramuscular antipsychotic in the 4 hours before study intervention
4. Use of depot antipsychotic within one dose interval before study intervention
5. Clinically significant acute or chronic pulmonary disease/ clinically significant hepatic, renal, gastroenterological, cardiovascular, neurological or hematological disease
6. Pregnant or lactating females
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Psychiatric conditions
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Intervention(s)
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Eligible participants would be randomized to receive either intramuscular haloperidol (5-10 mg) or intramuscular olanzapine (10 mg). All doses would be at the discretion of the attending doctor and will be within the currently recommended therapeutic dose range
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Primary Outcome(s)
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1. Positive and Negative Symptoms Scale – Excited Component (PANSS–EC)
2. Clinical Global Impression Scale (CGI)
3. Agitation Calmness Evaluation Scale (ACES)
4. Overt Aggression scale (OAS)
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Secondary Outcome(s)
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1. Proportion of patients requiring medical attention due to continued agitation
2. Proportion of patients requiring physical restraining
3. Proportion of that needed additional medication
4. Extrapyramidal side effects with Simpson Angus Extrapyramidal symptom scale and Barnes akathisia scale
5. Vital signs (heart rate, respiratory rate,systolic and diastolic blood pressure)
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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None
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