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ISRCTN
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ISRCTN83261243
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ClinicalTrials.gov identifier
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Public title
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TREC2 - Rapid tranquillisation for agitated patients in emergency psychiatric rooms in Rio de Janeiro. A randomised trial of intramuscular Haloperidol versus intramuscular Haloperidol + Promethazine.
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Scientific title
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Acronym
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TREC - Rapid Tranquillisation Clinical Trial (Tranquilização Rápida-Ensaio Clínico)
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Serial number at source
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N/A
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Study hypothesis
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The trial was undertaken to test the risks and benefits of adding promethazine to haloperidol for rapid intramuscular tranquillisation.
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Lay summary
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Ethics approval
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Not provided at time of registration
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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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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
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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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06/01/2004
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Anticipated end date
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01/07/2004
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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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600
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Interventions
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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.
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Primary outcome measure(s)
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Tranquil or asleep by 20 minutes after medication is given
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Secondary outcome measure(s)
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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
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Sources of funding
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1. The National Council for Research and Development (Consejo Nacional de Desarrollo Cientifico y Tecnologico [CNPq]) (Brazil)
2. Regional Health Authorities (Brazil) - donated drugs
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Trial website
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http://www.fotolog.net/trec
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17954515
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Contact name
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Dr
Gisele
Huf
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Address
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INCQS-FIOCRUZ
Av. Brasil 4365 Manguinhos
Cx. Postal: 926
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City/town
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Rio de Janeiro
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Zip/Postcode
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21045-900
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Country
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Brazil
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Tel
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+55 21 3865 5112
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Fax
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+55 21 2290 0915
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Email
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gisele@ensp.fiocruz.br
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Sponsor
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National School of Public Health (ENSP), Oswaldo Cruz Foundation (FIOCRUZ) (Brazil)
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Address
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Rua Leopoldo Bulhões 4036/816 Manguinhos
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City/town
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Rio de Janeiro
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Zip/Postcode
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21041-210
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Country
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Brazil
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Sponsor website:
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http://www.ensp.fiocruz.br
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Date applied
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31/08/2005
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Last edited
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01/11/2007
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Date ISRCTN assigned
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13/09/2005
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