Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro
| ISRCTN | ISRCTN44153243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44153243 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/03/2002
- Registration date
- 08/03/2002
- Last edited
- 21/05/2019
- 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
Oswaldo Cruz Foundation
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
Rio de Janeiro
RJ 21041-210
Brazil
| Phone | +55 (21) 2598 2622 |
|---|---|
| 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 | Quality of life |
| Scientific title | Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro |
| Study acronym | TREC-Rio = Rapid Tranquillisation Clinical Trial (Tranquilizacao Rapida-Ensaio Clinico) |
| Study objectives | TREC-Rio will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro, Brazil. |
| Ethics approval(s) | TREC-Rio has been approved by the ethics committees of institutions in charge of research and local ethics committees of each hospital involved. |
| 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]) 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Midazolam, haloperidol-promethazine |
| Primary outcome measure | Tranquillisation at 20 minutes. |
| Secondary outcome measures | Effects on other measures of morbidity, recorded at 24 hours and two weeks. |
| Overall study start date | 01/01/2003 |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 300 |
| Total final enrolment | 301 |
| Key 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. |
| 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 | 01/01/2003 |
| Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Oswaldo Cruz Foundation
Rio de Janeiro
RJ 21041-210
Brazil
RJ 21041-210
Brazil
Sponsor information
Oswaldo Cruz Foundation (Brazil)
Research organisation
Research organisation
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
Rio de Janeiro
RJ 21041-210
Brazil
| Website | http://www.fiocruz.br |
|---|---|
"ROR" |
https://ror.org/04jhswv08 |
Funders
Funder type
Government
There are no specific extramural funds.
No information available
The British Council (UK) - facilitated international contact
No information available
CAPES Foundation (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior) (Brazil) - facilitated international contact
No information available
The Ministry of Health (Brazil) - seconded the principal investigator for 2 years
No information available
Regional Health Authorities (Brazil) - donated drugs
No information available
The Cochrane Schizophrenia Group (UK) - supported with funding for sundries
No information available
The doctors and nurses of Rio freely gave support, enthusiasm and skill.
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/10/2002 | Yes | No | |
| Results article | results | 27/09/2003 | 21/05/2019 | Yes | No |
Editorial Notes
21/05/2019: Publication reference and total final enrolment added.
