Psychiatric conditions
Conditions
Interventions
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 wi
Sponsors
Dr Varuni de Silva,
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Symptoms Scale – Excited Component (PANSS–EC) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention] Clinical Global Impression Scale (CGI) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention] Agitation Calmness Evaluation Scale (ACES) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention ] Overt Aggression scale (OAS) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients requiring medical attention due to continued agitation [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention] Proportion of patients requiring physical restraining [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention] Proportion of that needed additional medication [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention] Extrapyramidal side effects with Simpson Angus Extrapyramidal symptom scale and Barnes akathisia scale [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention] Vital signs (heart rate, respiratory rate,systolic and diastolic blood pressure) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention] | — |
Countries
Sri Lanka
Contacts
Public ContactDr Hiranya Wijesundara
Senior Registrar in Psychiatry
Outcome results
None listed