Email updates

Keep up to date with the latest news and content from BMC Psychiatry and BioMed Central.

Open Access Study protocol

TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243]

Gisele Huf1*, Evandro SF Coutinho1 and Clive E Adams2

Author Affiliations

1 Oswaldo Cruz Foundation – FIOCRUZ, Av. Brasil, 4635 – Manguinhos, Rio de Janeiro – Brazil

2 The Cochrane Schizophrenia Group, Academic Unit of Psychiatry and Behavioural Sciences, University of Leeds, 15 Hyde Terrace, Leeds, LS2 9LT, UK

For all author emails, please log on.

BMC Psychiatry 2002, 2:11  doi:10.1186/1471-244X-2-11

Published: 16 October 2002

Abstract

Background

Agitated or violent patients constitute 10% of all emergency psychiatric treatment. Management guidelines, the preferred treatment of clinicians and clinical practice all differ. Systematic reviews show that all relevant studies are small and none are likely to have adequate power to show true differences between treatments. Worldwide, current treatment is not based on evidence from randomised trials. In Brazil, the combination haloperidol-promethazine is frequently used, but no studies involving this mix exist.

Methods

TREC-Rio (Tranquilização Rápida-Ensaio Clínico [Translation: Rapid Tranquillisation-Clinical Trial]) will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro, Brazil. TREC-Rio is a randomised, controlled, pragmatic and open study. Primary measure of outcome is tranquillisation at 20 minutes but effects on other measures of morbidity will also be assessed.

TREC-Rio will involve the collaboration of as many health care professionals based in four psychiatric emergency rooms of Rio as possible. Because the design of this trial does not substantially complicate clinical management, and in several aspects simplifies it, the study can be large, and treatments used in everyday practice can be evaluated.