TREC2 - Rapid tranquillisation for agitated patients in emergency psychiatric rooms in Rio de Janeiro. A randomised trial of intramuscular Haloperidol versus intramuscular Haloperidol + Promethazine.

ISRCTN	ISRCTN83261243
DOI	https://doi.org/10.1186/ISRCTN83261243
Protocol serial number	N/A
Sponsor	National School of Public Health (ENSP), Oswaldo Cruz Foundation (FIOCRUZ) (Brazil)
Funders	The National Council for Research and Development (Consejo Nacional de Desarrollo Cientifico y Tecnologico [CNPq]) (Brazil), Regional Health Authorities (Brazil) - donated drugs

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Gisele Huf
Scientific

INCQS-FIOCRUZ
Av. Brasil 4365 Manguinhos
Cx. Postal: 926
Rio de Janeiro
21045-900
Brazil

Phone	+55 21 3865 5112
Email	gisele@ensp.fiocruz.br

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TREC - Rapid Tranquillisation Clinical Trial (Tranquilização Rápida-Ensaio Clínico)
Study objectives	The trial was undertaken to test the risks and benefits of adding promethazine to haloperidol for rapid intramuscular tranquillisation.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Serious mental illnesses combined with overt aggression or violence
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Promethazine, haloperidol
Primary outcome measure(s)	Tranquil or asleep by 20 minutes after medication is given
Key secondary outcome measure(s)	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
Completion date	01/07/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	600
Key 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
Key exclusion criteria	People are not eligible for trial entry if the clinician believes that one treatment represents an additional risk for the patient
Date of first enrolment	06/01/2004
Date of final enrolment	01/07/2004

INCQS-FIOCRUZ

Rio de Janeiro
21045-900
Brazil

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	27/10/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes