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Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro
ISRCTN ISRCTN44153243
DOI 10.1186/ISRCTN44153243
ClinicalTrials.gov identifier
EudraCT number
Public title Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro
Scientific title
Acronym TREC-Rio = Rapid Tranquillisation Clinical Trial (Tranquilizacao Rapida-Ensaio Clinico)
Serial number at source N/A
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.
Lay summary
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
Countries of recruitment Brazil
Disease/condition/study domain Serious mental illnesses combined with overt aggression or violence
Participants - 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.
Participants - exclusion criteria People are not eligible for trial entry if the clinician believes that one treatment represents an additional risk for the patient.
Anticipated start date 01/01/2003
Anticipated end date 01/01/2004
Status of trial Completed
Patient information material
Target number of participants 300
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 attending doctors.
Primary outcome measure(s) Tranquillisation at 20 minutes.
Secondary outcome measure(s) Effects on other measures of morbidity, recorded at 24 hours and two weeks.
Sources of funding There are no specific extramural funds.
1. The British Council (UK) - facilitated international contact
2. CAPES Foundation (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior) (Brazil) - facilitated international contact
3. The Ministry of Health (Brazil) - seconded the principal investigator for 2 years
4. Regional Health Authorities (Brazil) - donated drugs
5. The Cochrane Schizophrenia Group (UK) - supported with funding for sundries

The doctors and nurses of Rio freely gave support, enthusiasm and skill.
Trial website
Publications Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12383353
Contact name Dr  Gisele  Huf
  Address Oswaldo Cruz Foundation
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
  City/town Rio de Janeiro
  Zip/Postcode RJ 21041-210
  Country Brazil
  Tel +55 (21) 2598 2622
  Fax +55 (21) 2270 6772
  Email gisele@ensp.fiocruz.br
Sponsor Oswaldo Cruz Foundation (Brazil)
  Address National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
  City/town Rio de Janeiro
  Zip/Postcode RJ 21041-210
  Country Brazil
  Sponsor website: http://www.fiocruz.br
Date applied 08/03/2002
Last edited 06/09/2007
Date ISRCTN assigned 08/03/2002
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