Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gisele Huf
ORCID ID
Contact details
INCQS-FIOCRUZ
Av. Brasil 4365 Manguinhos
Cx. Postal: 926
Rio de Janeiro
21045-900
Brazil
+55 21 3865 5112
gisele@ensp.fiocruz.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TREC - Rapid Tranquillisation Clinical Trial (Tranquilização Rápida-Ensaio Clínico)
Study hypothesis
The trial was undertaken to test the risks and benefits of adding promethazine to haloperidol for rapid intramuscular tranquillisation.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Serious mental illnesses combined with overt aggression or violence
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Promethazine, haloperidol
Primary outcome measures
Tranquil or asleep by 20 minutes after medication is given
Secondary outcome measures
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
Overall trial start date
06/01/2004
Overall trial end date
01/07/2004
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
600
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
06/01/2004
Recruitment end date
01/07/2004
Locations
Countries of recruitment
Brazil
Trial participating centre
INCQS-FIOCRUZ
Rio de Janeiro
21045-900
Brazil
Sponsor information
Organisation
National School of Public Health (ENSP), Oswaldo Cruz Foundation (FIOCRUZ) (Brazil)
Sponsor details
Rua Leopoldo Bulhões 4036/816 Manguinhos
Rio de Janeiro
21041-210
Brazil
Sponsor type
Charity
Website
Funders
Funder type
Research council
Funder name
The National Council for Research and Development (Consejo Nacional de Desarrollo Cientifico y Tecnologico [CNPq]) (Brazil)
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
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
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17954515
Publication citations
-
Results
Huf G, Coutinho ES, Adams CE, , Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine., BMJ, 2007, 335, 7625, 869, doi: 10.1136/bmj.39339.448819.AE.