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ISRCTN
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ISRCTN44153243
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ClinicalTrials.gov identifier
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Public title
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Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro
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Scientific title
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Acronym
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TREC-Rio = Rapid Tranquillisation Clinical Trial (Tranquilizacao Rapida-Ensaio Clinico)
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Serial number at source
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N/A
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Study hypothesis
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TREC-Rio will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro, Brazil.
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Ethics approval
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TREC-Rio has been approved by the ethics committees of institutions in charge of research and local ethics committees of each hospital involved.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Serious mental illnesses combined with overt aggression or violence
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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People are not eligible for trial entry if the clinician believes that one treatment represents an additional risk for the patient.
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Anticipated start date
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01/01/2003
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Anticipated end date
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01/01/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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300
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Interventions
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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.
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Primary outcome measure(s)
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Tranquillisation at 20 minutes.
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Secondary outcome measure(s)
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Effects on other measures of morbidity, recorded at 24 hours and two weeks.
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Sources of funding
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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.
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12383353
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Contact name
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Dr
Gisele
Huf
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Address
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Oswaldo Cruz Foundation
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
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City/town
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Rio de Janeiro
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Zip/Postcode
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RJ 21041-210
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Country
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Brazil
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Tel
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+55 (21) 2598 2622
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Fax
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+55 (21) 2270 6772
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Email
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gisele@ensp.fiocruz.br
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Sponsor
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Oswaldo Cruz Foundation (Brazil)
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Address
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National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
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City/town
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Rio de Janeiro
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Zip/Postcode
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RJ 21041-210
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Country
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Brazil
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Sponsor website:
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http://www.fiocruz.br
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Date applied
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08/03/2002
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Last edited
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06/09/2007
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Date ISRCTN assigned
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08/03/2002
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