Physical restraints versus seclusion room for management of people with acute aggression or agitation due to psychotic illness (TREC-SAVE): a randomized trial.

BACKGROUND: After de-escalation techniques have failed, restraints, seclusion and/or rapid tranquillization may be used for people whose aggression is due to psychosis. Most coercive acts of health care have not been evaluated in trials.

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. The primary outcomes were 'no need to change intervention early - within 1 h' and 'not restricted by 4 h'.

RESULTS: A total of 105 people were randomized. Two-thirds of the people secluded were able to be fully managed in this way. 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 [not restricted by 4 h: relative risk 1.09, 95% confidence interval 0.75-1.58; mean time to release: restraints 337.6 (s.d.=298.2) min, seclusion room 316.3 (s.d.=264.5) min, p=0.48]. Participants tended to be more satisfied with their care in the seclusion group (17.0% v. 11.1%) but this did not reach conventional levels of statistical significance (p=0.42).

CONCLUSIONS: This study should be replicated, but suggests that opting for the least restrictive option in circumstances where there is clinical doubt does not harm or prolong coercion.