Contact information
Type
Scientific
Primary contact
Dr Gisele Huf
ORCID ID
Contact details
Oswaldo Cruz Foundation
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
Rio de Janeiro
RJ 21041-210
Brazil
+55 (21) 2598 2622
gisele@ensp.fiocruz.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TREC-Rio = Rapid Tranquillisation Clinical Trial (Tranquilizacao Rapida-Ensaio Clinico)
Study hypothesis
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
TREC-Rio has been approved by the ethics committees of institutions in charge of research and local ethics committees of each hospital involved.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
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 names
Midazolam, haloperidol-promethazine
Primary outcome measures
Tranquillisation at 20 minutes.
Secondary outcome measures
Effects on other measures of morbidity, recorded at 24 hours and two weeks.
Overall trial start date
01/01/2003
Overall trial end date
01/01/2004
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
300
Participant exclusion criteria
People are not eligible for trial entry if the clinician believes that one treatment represents an additional risk for the patient.
Recruitment start date
01/01/2003
Recruitment end date
01/01/2004
Locations
Countries of recruitment
Brazil
Trial participating centre
Oswaldo Cruz Foundation
Rio de Janeiro
RJ 21041-210
Brazil
Sponsor information
Organisation
Oswaldo Cruz Foundation (Brazil)
Sponsor details
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
Rio de Janeiro
RJ 21041-210
Brazil
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
There are no specific extramural funds.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The British Council (UK) - facilitated international contact
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
CAPES Foundation (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior) (Brazil) - facilitated international contact
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Ministry of Health (Brazil) - seconded the principal investigator for 2 years
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Regional Health Authorities (Brazil) - donated drugs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Cochrane Schizophrenia Group (UK) - supported with funding for sundries
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The doctors and nurses of Rio freely gave support, enthusiasm and skill.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12383353
Publication citations
-
Protocol
Huf G, Coutinho ES, Adams CE, , TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243]., BMC Psychiatry, 2002, 2, 11.