TREC2 - Rapid tranquillisation for agitated patients in emergency psychiatric rooms in Rio de Janeiro. A randomised trial of intramuscular Haloperidol versus intramuscular Haloperidol + Promethazine.
| ISRCTN | ISRCTN83261243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83261243 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/08/2005
- Registration date
- 13/09/2005
- Last edited
- 01/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gisele Huf
Scientific
Scientific
INCQS-FIOCRUZ
Av. Brasil 4365 Manguinhos
Cx. Postal: 926
Rio de Janeiro
21045-900
Brazil
| Phone | +55 21 3865 5112 |
|---|---|
| gisele@ensp.fiocruz.br |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TREC - Rapid Tranquillisation Clinical Trial (Tranquilização Rápida-Ensaio Clínico) |
| Study objectives | The trial was undertaken to test the risks and benefits of adding promethazine to haloperidol for rapid intramuscular tranquillisation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Promethazine, haloperidol |
| Primary outcome measure | 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 study start date | 06/01/2004 |
| Completion date | 01/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 600 |
| Key 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 |
| Key exclusion criteria | People are not eligible for trial entry if the clinician believes that one treatment represents an additional risk for the patient |
| Date of first enrolment | 06/01/2004 |
| Date of final enrolment | 01/07/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
INCQS-FIOCRUZ
Rio de Janeiro
21045-900
Brazil
21045-900
Brazil
Sponsor information
National School of Public Health (ENSP), Oswaldo Cruz Foundation (FIOCRUZ) (Brazil)
Charity
Charity
Rua Leopoldo Bulhões 4036/816 Manguinhos
Rio de Janeiro
21041-210
Brazil
| Website | http://www.ensp.fiocruz.br |
|---|---|
"ROR" |
https://ror.org/04jhswv08 |
Funders
Funder type
Research council
The National Council for Research and Development (Consejo Nacional de Desarrollo Cientifico y Tecnologico [CNPq]) (Brazil)
No information available
Regional Health Authorities (Brazil) - donated drugs
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 27/10/2007 | Yes | No |
