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

ISRCTN	ISRCTN44153243
DOI	https://doi.org/10.1186/ISRCTN44153243
Protocol serial number	N/A
Sponsor	Oswaldo Cruz Foundation (Brazil)
Funders	There are no specific extramural funds., The British Council (UK) - facilitated international contact, CAPES Foundation (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior) (Brazil) - facilitated international contact, The Ministry of Health (Brazil) - seconded the principal investigator for 2 years, Regional Health Authorities (Brazil) - donated drugs, The Cochrane Schizophrenia Group (UK) - supported with funding for sundries, The doctors and nurses of Rio freely gave support, enthusiasm and skill.

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

Oswaldo Cruz Foundation
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
Rio de Janeiro
RJ 21041-210
Brazil

Phone	+55 (21) 2598 2622
Email	gisele@ensp.fiocruz.br

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro
Study acronym	TREC-Rio = Rapid Tranquillisation Clinical Trial (Tranquilizacao Rapida-Ensaio Clinico)
Study objectives	TREC-Rio will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro, Brazil.
Ethics approval(s)	TREC-Rio has been approved by the ethics committees of institutions in charge of research and local ethics committees of each hospital involved.
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]) 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 attending doctors.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Midazolam, haloperidol-promethazine
Primary outcome measure(s)	Tranquillisation at 20 minutes.
Key secondary outcome measure(s)	Effects on other measures of morbidity, recorded at 24 hours and two weeks.
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	300
Total final enrolment	301
Key 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.
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	01/01/2003
Date of final enrolment	01/01/2004

Oswaldo Cruz Foundation

Rio de Janeiro
RJ 21041-210
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	27/09/2003	21/05/2019	Yes	No
Protocol article	protocol	16/10/2002		Yes	No

21/05/2019: Publication reference and total final enrolment added.