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Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro

Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44153243
Enrollment
300
Registered
2002-03-08
Start date
2003-01-01
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serious mental illnesses combined with overt aggression or violence Mental and Behavioural Disorders Aggression or violence in mental illness

Interventions

1. Haloperidol (up to 10 mg intramuscular [IM]) with promethazine (up to 50 mg IM) 2. Midazolam (up to 15 mg IM) Doses are not fixed and are at the discretion of the a

Sponsors

Oswaldo Cruz Foundation (Brazil)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. It is clear that they need acute intramuscular sedation because of disturbed and dangerous behaviour thought to be due to serious mental illness; and 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

MeasureTime frame
Tranquillisation at 20 minutes.

Secondary

MeasureTime frame
Effects on other measures of morbidity, recorded at 24 hours and two weeks.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026