Condition category
Mental and Behavioural Disorders
Date applied
31/08/2005
Date assigned
13/09/2005
Last edited
01/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.fotolog.net/trec

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

http://www.ensp.fiocruz.br

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

  1. 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.

Additional files

Editorial Notes