Serious mental illnesses combined with overt aggression or violence Mental and Behavioural Disorders Aggression or violence
Conditions
Interventions
1. Haloperidol (up to 10 mg intramuscular [IM])
2. Haloperidol (up to 10 mg IM) with promethazine (up to 50 mg IM)
Doses are not fixed and are at the discretion of the attending doctors.
Sponsors
National School of Public Health (ENSP), Oswaldo Cruz Foundation (FIOCRUZ) (Brazil)
Eligibility
Inclusion criteria
Inclusion criteria: People are eligible for trial entry if: 1. It is clear that they need acute intramuscular sedation because of disturbed and dangerous behaviour thought to be due to serious mental illness 2. The clinician is uncertain about the benefits and risks of the comparator medications
Exclusion criteria
Exclusion criteria: People are not eligible for trial entry if the clinician believes that one treatment represents an additional risk for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tranquil or asleep by 20 minutes after medication is given | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Asleep by 20 minutes 2. Tranquil or asleep by 40, 60 and 120 minutes 3. Physically restrained or given additional medication within 2 hours 4. Severe adverse events during the subsequent 24 hours 5. Another episode of agitation/aggression during the subsequent 24 hours 6. Needing additional visits from the doctor during the subsequent 24 hours 7. Overall antipsychotic load in the first 24 hours 8. Still in hospital after 2 weeks | — |
Countries
Brazil
Outcome results
None listed