title: TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243].
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.
authors.affiliation: Oswaldo Cruz Foundation - FIOCRUZ, Av, Brasil, 4635 - Manguinhos, Rio de Janeiro, Brazil. gisele@ensp.fiocruz.br
authors.forename: Gisele
authors.initials: G
authors.lastname: Huf
authors.forename: Evandro S F
authors.initials: ES
authors.lastname: Coutinho
authors.forename: Clive E
authors.initials: CE
authors.lastname: Adams
mesh_terms: D001938:Brazil; D002985:Clinical Protocols / Q000592:standards*; D004338:Drug Combinations; D004637:Emergency Services, Psychiatric / Q000458:organization & administration*; D032984:Ethics, Research; D006220:Haloperidol / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy* / Q000523:psychology; D008874:Midazolam / Q000627:therapeutic use*; D018579:Patient Selection; D010919:Placebos; D011398:Promethazine / Q000008:administration & dosage / Q000627:therapeutic use*; D011595:Psychomotor Agitation / Q000188:drug therapy / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design
chemical_list: D004338:Drug Combinations; D010919:Placebos; D011398:Promethazine; D006220:Haloperidol; D008874:Midazolam