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Physical restraints versus seclusion room for management of people with acute aggression or agitation due to psychotic illness (TREC-SAVE): a randomised trial (ISRCTN 49454276). Gisele Huf 1,2 Evandro Silva Freire Coutinho 3 Clive E Adams 4 TREC-SAVE Collaborative Group
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Physical restraints versus seclusion room for management of people with acute aggression or agitation due to psychotic illness (TREC-SAVE): a randomised trial (ISRCTN 49454276) Gisele Huf1,2 Evandro Silva Freire Coutinho3 Clive E Adams4 TREC-SAVE Collaborative Group 1. National Institute of Quality Control in Health – Oswaldo Cruz Foundation, Rio de Janeiro, Brazil 2. University Hospital Clementino Fraga Filho – Federal Universityof Rio de Janeiro, Rio de Janeiro, Brazil 3. NationalSchoolofPublic Health - Oswaldo Cruz Foundation, Rio de Janeiro, Brazil 4. Division of Psychiatry, Institute of Mental Health, University of Nottingham, UK Background After de-escalation techniques have failed, restraints, seclusion and/or rapid tranquillisation may be used for people whose aggression is due to psychosis. Most coercive acts of heath care have not been evaluated in trials. Lack of fair testing leaves mental health services unnecessarily open to criticism Method People admitted to the Emergency Room of Instituto Philippe Pinel, Rio de Janeiro, Brazil, whose aggression/agitation was thought due to psychosis and for whom staff were unsure if best to restrict using physical restraints or a seclusion room, were randomly allocated to one or the other and followed up to 14 days (primary outcome - ‘No need to early change allocated treatment – within 1 hour’ and ‘Not restricted - by 4 hours’). Findings 105 people were randomised. Two thirds of people secluded were able to be fully managed in this way. Many more trials need to be undertaken in this under-researched area CONSORT Conclusion Even taking into account the move out of seclusion into restraints this study provides evidence that embarking on the less restrictive care pathway (seclusion) does not increase overall time in restriction of some sort (RR Not restricted - by 4 hours 1.09 CI 0.75-1.58; mean time to release: restraints 337.6 minutes (SD 298.2), seclusion room 316.3 minutes (SD 264.5), p=0.48). Participants tended to be more satisfied with their care in the seclusiongroup (17.0% vs 11.1%) but this did not reach conventional levels of statistical significance (p=0.42). Total time to end of restriction Reference: PsycholMed. 2012 Nov;42(11):2265-73. doi: 10.1017/S0033291712000372. Correspondence: Clive.adams@nottingham.ac.uk