Condition category
Mental and Behavioural Disorders
Date applied
08/03/2002
Date assigned
08/03/2002
Last edited
06/09/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gisele Huf

ORCID ID

Contact details

Oswaldo Cruz Foundation
National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
Rio de Janeiro
RJ 21041-210
Brazil
+55 (21) 2598 2622
gisele@ensp.fiocruz.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TREC-Rio = Rapid Tranquillisation Clinical Trial (Tranquilizacao Rapida-Ensaio Clinico)

Study hypothesis

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

TREC-Rio has been approved by the ethics committees of institutions in charge of research and local ethics committees of each hospital involved.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Midazolam, haloperidol-promethazine

Primary outcome measures

Tranquillisation at 20 minutes.

Secondary outcome measures

Effects on other measures of morbidity, recorded at 24 hours and two weeks.

Overall trial start date

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

300

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

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

Brazil

Trial participating centre

Oswaldo Cruz Foundation
Rio de Janeiro
RJ 21041-210
Brazil

Sponsor information

Organisation

Oswaldo Cruz Foundation (Brazil)

Sponsor details

National School of Public Health
Manguinhos
Av. Leopoldo Bulhões 1480/sala 816
Rio de Janeiro
RJ 21041-210
Brazil

Sponsor type

Research organisation

Website

http://www.fiocruz.br

Funders

Funder type

Government

Funder name

There are no specific extramural funds.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The British Council (UK) - facilitated international contact

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CAPES Foundation (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior) (Brazil) - facilitated international contact

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Ministry of Health (Brazil) - seconded the principal investigator for 2 years

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

Funder name

The Cochrane Schizophrenia Group (UK) - supported with funding for sundries

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The doctors and nurses of Rio freely gave support, enthusiasm and skill.

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

Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=12383353

Publication citations

  1. Protocol

    Huf G, Coutinho ES, Adams CE, , TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243]., BMC Psychiatry, 2002, 2, 11.

Additional files

Editorial Notes