Dataset Information

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.

SUBMITTER: Huf G

PROVIDER: S-EPMC134470 | biostudies-literature | 2002 Oct

REPOSITORIES: biostudies-literature

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

Huf Gisele G Coutinho Evandro S F ES Adams Clive E CE

BMC psychiatry 20021016

<h4>Background</h4>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 ...[more]

PMID: 12383353

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Project description:ObjectiveTo compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness.DesignPragmatic, allocation concealed, randomised controlled trial.SettingEmergency services of a general hospital psychiatry department in Vellore, south India.Participants300 adults with agitated or violent behaviour as a result of mental illness; 150 randomised to intramuscular olanzapine and 150 randomised to intramuscular haloperidol plus promethazine.InterventionsOpen treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine.Main outcome measuresPrimary outcome was proportion of patients who were tranquil or asleep at 15 minutes and 240 minutes. Secondary outcomes were proportion of patients who were tranquil, asleep, restrained, absconding, or clinically improved at 15, 30, 60, 120, and 240 minutes; additional medical interventions and adverse effects over four hours; and compliance with oral drugs and adverse effects over two weeks.ResultsOf 300 people randomised to receive either intramuscular olanzapine or intramuscular haloperidol plus promethazine, follow-up data were available for primary outcomes for 298 (99%). Both treatments resulted in similar proportions of people being tranquil or asleep at 15 minutes (olanzapine 131/150 (87%), haloperidol plus promethazine 136/150 (91%); relative risk 0.96, 95% confidence interval 0.34 to 1.47) and 240 minutes (olanzapine 144/150 (96%), haloperidol plus promethazine 145/150 (97%); relative risk 0.99, 0.95 to 1.03). However, more people given olanzapine than those given haloperidol plus promethazine required additional drugs over four hours (65/150 (43%) v 31/150 (21%); relative risk 2.07, 1.43 to 2.97). Adverse effects were uncommon with both treatments.ConclusionsIntramuscular olanzapine and intramuscular haloperidol plus promethazine were effective at rapidly tranquillising or sedating agitated or violent patients with mental illness but the combination resulted in fewer additional medical interventions within four hours of intervention.Trial registrationClinical trials NCT00455234 [ClinicalTrials.gov].

Project description:BackgroundAgitation is common in people with dementia and negatively affects the quality of life of both people with dementia and carers. Non-drug patient-centred care is the first-line treatment, but there is a need for other treatment when this care is not effective. Current evidence is sparse on safer and effective alternatives to antipsychotics. We assessed the efficacy and safety of mirtazapine, an antidepressant prescribed for agitation in dementia.MethodsThis parallel-group, double-blind, placebo-controlled trial-the Study of Mirtazapine for Agitated Behaviours in Dementia trial (SYMBAD)-was done in 26 UK centres. Participants had probable or possible Alzheimer's disease, agitation unresponsive to non-drug treatment, and a Cohen-Mansfield Agitation Inventory (CMAI) score of 45 or more. They were randomly assigned (1:1) to receive either mirtazapine (titrated to 45 mg) or placebo. The primary outcome was reduction in CMAI score at 12 weeks. This trial is registered with ClinicalTrials.gov, NCT03031184, and ISRCTN17411897.FindingsBetween Jan 26, 2017, and March 6, 2020, 204 participants were recruited and randomised. Mean CMAI scores at 12 weeks were not significantly different between participants receiving mirtazapine and participants receiving placebo (adjusted mean difference -1·74, 95% CI -7·17 to 3·69; p=0·53). The number of controls with adverse events (65 [64%] of 102 controls) was similar to that in the mirtazapine group (67 [66%] of 102 participants receiving mirtazapine). However, there were more deaths in the mirtazapine group (n=7) by week 16 than in the control group (n=1), with post-hoc analysis suggesting this difference was of marginal statistical significance (p=0·065).InterpretationThis trial found no benefit of mirtazapine compared with placebo, and we observed a potentially higher mortality with use of mirtazapine. The data from this study do not support using mirtazapine as a treatment for agitation in dementia.FundingUK National Institute for Health Research Health Technology Assessment Programme.

Project description:BackgroundInterest in sensory rooms or so-called "calm rooms" in psychiatric inpatient care has increased significantly. In a hospital setting, their purpose is to introduce a relaxing environment to increase well-being as well as to decrease anxiety and aggressive behaviors. Calm rooms can also be used as a tool to provide self-help through a convenient environment for the patients and, at the same time, strengthen the therapeutic relationship between the patient and the professional. Recent developments in virtual reality (VR) have made virtual calm rooms possible, but these have not yet been evaluated in psychiatric inpatient care.ObjectiveThis study aimed to compare the effects of VR and physical calm rooms on self-reported well-being and physiological markers of arousal.MethodsThe study was conducted in 2 inpatient psychiatric wards specializing in bipolar disorder from March 2019 to February 2021. Patients who were already admitted were asked if they were interested in using a calm room and willing to provide ratings. This study relied on the quasi-randomized allocation of patients to the wards, which either had a physical or VR calm room. Self-assessment scales (Montgomery-Åsberg Depression Rating Scale-Self Assessment [MADRS-S], Beck Anxiety Scale, and Clinical Global Impression) were used to determine the participants' baseline level of depressive and anxiety symptoms before their use of the physical or VR calm room. The study determined the state of well-being measured using an 11-point visual analog scale (VAS) as well as arousal measured by blood pressure (systolic and diastolic) and heart rate before and after the use of the calm rooms. The primary end point was self-reported well-being using the VAS.ResultsA total of 60 participants were included-40 used the VR calm room and 20 used the physical calm room. The mean age of participants was 39 years and the majority were women (35/60, 58%). Analysis of VAS measurement showed improved well-being at the group level from before to after the intervention (P<.05), with no statistically significant difference in effects between the 2 different interventions. Effects were not moderated by baseline depression levels (dichotomized as MADRS-S >20 or ≤20) despite an overall difference in reported well-being between subgroups.ConclusionsAlthough the power in this study was low, the findings of this first study indicate comparable effects with respect to well-being and arousal of a VR calm room and a physical calm room. This suggests that a VR calm room can be a viable alternative when the use of a physical calm room is not an option for logistic or other reasons.Trial registrationClinicalTrials.gov NCT03918954; https://clinicaltrials.gov/ct2/show/NCT03918954.

Project description:BackgroundSuicidal behaviour is common in acute psychiatric wards resulting in distress, and burden for patients, carers and society. Although psychological therapies for suicidal behaviour are effective in out-patient settings, there is little research on their effectiveness for in-patients who are suicidal.AimsOur primary objective was to determine whether cognitive-behavioural suicide prevention therapy (CBSP) was feasible and acceptable, compared with treatment as usual (TAU) for in-patients who are suicidal. Secondary aims were to assess the impact of CBSP on suicidal thinking, behaviours, functioning, quality of life, service use, cost-effectiveness and psychological factors associated with suicide.MethodA single-blind pilot randomised controlled trial comparing TAU to TAU plus CBSP in in-patients in acute psychiatric wards who are suicidal (the Inpatient Suicide Intervention and Therapy Evaluation (INSITE) trial, trial registration: ISRCTN17890126). The intervention consisted of TAU plus up to 20 CBSP sessions, over 6 months continuing in the community following discharge. Participants were assessed at baseline and at 6 weeks and 6 months post-baseline.ResultsA total of 51 individuals were randomised (27 to TAU, 24 to TAU plus CBSP) of whom 37 were followed up at 6 months (19 in TAU, 18 in TAU plus CBSP). Engagement, attendance, safety and user feedback indicated that the addition of CBSP to TAU for in-patients who are acutely suicidal was feasible and acceptable while on in-patient wards and following discharge. Economic analysis suggests the intervention could be cost-effective.DiscussionPsychological therapy can be delivered safely to patients who are suicidal although modifications are required for this setting. Findings indicate a larger, definitive trial should be conducted.Declaration of interestThe trial was hosted by Greater Manchester Mental health NHS Trust (formerly, Manchester Mental Health and Social Care NHS Trust). The authors are affiliated to the University of Manchester, Greater Manchester Mental Health Foundation Trust, Lancashire Care NHS Foundation trust and the Manchester Academic Health Sciences Centre. Y.A. is a trustee for a North-West England branch of the charity Mind.

Dataset Information

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

Publications

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

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