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Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.

ABSTRACT: To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness.Pragmatic, allocation concealed, randomised controlled trial.Emergency services of a general hospital psychiatry department in Vellore, south India.300 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.Open treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine.Primary 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.Of 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.Intramuscular 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.Clinical trials NCT00455234 [ClinicalTrials.gov].

SUBMITTER: Raveendran NS

PROVIDER: S-EPMC2043469 | biostudies-literature | 2007 Oct

REPOSITORIES: biostudies-literature

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Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.

Raveendran Nirmal S NS Tharyan Prathap P Alexander Jacob J Adams Clive Elliot CE

BMJ (Clinical research ed.) 20071022 7625

<h4>Objective</h4>To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness.<h4>Design</h4>Pragmatic, allocation concealed, randomised controlled trial.<h4>Setting</h4>Emergency services of a general hospital psychiatry department in Vellore, south India.<h4>Participants</h4>300 adults with agitated or violent behaviour as a result of mental illness; 150 randomised to intramuscula ...[more]

PMID: 17954514

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Project description:BackgroundPsychiatric advance directives, a tool to document preferences for care in advance of decisional incapacity, have been shown to benefit persons with mental illness in a number of countries through improving medication adherence, reducing symptoms from escalating in a crisis, accelerating recovery, and enhancing service user autonomy. While concepts such as autonomy are important in a number of high-income country settings, it remains unclear whether tools like psychiatric advance directives are suitable in a different context. The recent introduction of the psychiatric advance directive into draft legislation in India prompts the question as to how feasible psychiatric advance directives are in the Indian context. The aim of this study is to explore the feasibility and utility of PADs in India, with a focus on the need for individual control over decision making and barriers to implementation, by exploring views of its central stakeholders, service users and carers.MethodsQualitative semi-structured interviews (n = 51) with clients (n = 39) and carers (n = 12) seeking mental health treatment at outpatient clinics in urban and rural settings provided by a non-profit organisation in Tamil Nadu, India.ResultsClients engaged in a number of forms of decision-making (passive, active, and collaborative) depending on the situation and decision at hand, and had high levels of self-efficacy. Most clients and carers were unfamiliar with PADs, and while some clients felt it is important to have a say in treatment wishes, carers expressed concerns about service user capacity to make decisions. After completing PADs, clients reported an increase in self-efficacy and an increased desire to make decisions.ConclusionsThe introduction of psychiatric advance directives in India appears to be associated with positive outcomes for some service users, however, there is a need to better understand how this tool can be adapted to better suit the care context in India and hold meaning and value for service users to complete.

Project description:BACKGROUND:Treatment of delirium often includes haloperidol. Second-generation antipsychotics like olanzapine have emerged as an alternative with possibly fewer side effects. The aim of this multicenter, phase III, randomized clinical trial was to compare the efficacy and tolerability of olanzapine with haloperidol for the treatment of delirium in hospitalized patients with advanced cancer. MATERIALS AND METHODS:Eligible adult patients (?18?years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98 [DRS-R-98] total score ?17.75) were randomized 1:1 to receive either haloperidol or olanzapine (age-adjusted, titratable doses). Primary endpoint was delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score <15.25 and ?4.5 points reduction. Secondary endpoints included time to response (TTR), tolerability, and delirium-related distress. RESULTS:Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis. DRR was 45% (95% confidence interval [CI], 31-59) for olanzapine and 57% (95% CI, 43-71) for haloperidol (? DRR -12%; odds ratio [OR], 0.61; 95% CI, 0.2-1.4; p = .23). Mean TTR was 4.5?days (95% CI, 3.2-5.9?days) for olanzapine and 2.8?days (95% CI, 1.9-3.7?days; p = .18) for haloperidol. Grade ?3 treatment-related adverse events occurred in 5 patients (10.2%) and 10 patients (20.4%) in the olanzapine and haloperidol arm, respectively. Distress rates were similar in both groups. The study was terminated early because of futility. CONCLUSION:Delirium treatment with olanzapine in hospitalized patients with advanced cancer did not result in improvement of DRR or TTR compared with haloperidol. Clinical trial identification number. NCT01539733. Dutch Trial Register. NTR2559. IMPLICATIONS FOR PRACTICE:Guidelines recommend that pharmacological interventions for delirium treatment in adults with cancer should be limited to patients who have distressing delirium symptoms. It was suggested that atypical antipsychotics, such as olanzapine, outperform haloperidol in efficacy and safety. However, collective data comparing the efficacy and safety of typical versus atypical antipsychotics in patients with cancer are limited. If targeted and judicious use of antipsychotics is considered for the treatment of delirium in patients with advanced cancer, this study demonstrated that there was no statistically significant difference in response to haloperidol or olanzapine. Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.

Dataset Information

Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.

Publications

Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.

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