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Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon).

ABSTRACT: Background: Agitated and aggressive behaviours are common in the psychiatric setting and rapid tranquilisation is sometimes unavoidable. A survey of Lebanese practice has shown that an intramuscular haloperidol, promethazine and chlorpromazine combination is a preferred form of treatment but there are no randomised trials of this triple therapy. Methods: This is a pragmatic randomised trial. Setting - the psychiatric wards of the Psychiatric Hospital of the Cross, Jal Eddib, Lebanon. Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable, who has not been randomised before, for whom there are no known contraindications. Randomisation - stratified (by ward) randomisation and concealed in closed opaque envelope by independent parties. Procedure - if the clinical situation arises requiring rapid tranquilisation, medical residents overseeing the patient will open a TREC-Lebanon envelope in which will be notification of which group of treatments should be preferred [Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP)], along with forms for primary, secondary and serious adverse effects. Treatment is not given blindly. Outcome - primary outcome is calm or tranquil at 20 minutes post intervention. Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward. Follow-up will be up to two weeks post randomisation. Discussion: Findings from this study will compare the HPC versus HP combination used in Lebanon's psychiatry emergency routine practice. Trial registration: ClinicalTrials.gov NCT03639558. Registration date, August 21, 2018.

SUBMITTER: Dib JE

PROVIDER: S-EPMC7262571 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon).

Dib Joseph E JE Adams Clive E CE Ikdais Werner Henry WH Atallah Elie E Yaacoub Hiba Edward HE Merheb Tony Jean TJ Kazour Francois F Tahan Fouad F Haddad Georges G Zoghbi Marouan M Azar Jocelyn J Haddad Chadia C Hallit Souheil S

F1000Research 20190815

<b>Background:</b> Agitated and aggressive behaviours are common in the psychiatric setting and rapid tranquilisation is sometimes unavoidable. A survey of Lebanese practice has shown that an intramuscular haloperidol, promethazine and chlorpromazine combination is a preferred form of treatment but there are no randomised trials of this triple therapy. <b>Methods:</b> This is a pragmatic randomised trial. Setting - the psychiatric wards of the Psychiatric Hospital of the Cross, Jal Eddib, Lebano ...[more]

PMID: 32528650

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Project description: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].

Project description:The use of benzodiazepines to control agitation in delirium in the last days of life is controversial.To compare the effect of lorazepam vs placebo as an adjuvant to haloperidol for persistent agitation in patients with delirium in the setting of advanced cancer.Single-center, double-blind, parallel-group, randomized clinical trial conducted at an acute palliative care unit at MD Anderson Cancer Center, Texas, enrolling 93 patients with advanced cancer and agitated delirium despite scheduled haloperidol from February 11, 2014, to June 30, 2016, with data collection completed in October 2016.Lorazepam (3 mg) intravenously (n?=?47) or placebo (n?=?43) in addition to haloperidol (2 mg) intravenously upon the onset of an agitation episode.The primary outcome was change in Richmond Agitation-Sedation Scale (RASS) score (range, -5 [unarousable] to 4 [very agitated or combative]) from baseline to 8 hours after treatment administration. Secondary end points were rescue neuroleptic use, delirium recall, comfort (perceived by caregivers and nurses), communication capacity, delirium severity, adverse effects, discharge outcomes, and overall survival.Among 90 randomized patients (mean age, 62 years; women, 42 [47%]), 58 (64%) received the study medication and 52 (90%) completed the trial. Lorazepam?+?haloperidol resulted in a significantly greater reduction of RASS score at 8 hours (-4.1 points) than placebo?+?haloperidol (-2.3 points) (mean difference, -1.9 points [95% CI, -2.8 to -0.9]; P?<?.001). The lorazepam?+?haloperidol group required less median rescue neuroleptics (2.0 mg) than the placebo?+?haloperidol group (4.0 mg) (median difference, -1.0 mg [95% CI, -2.0 to 0]; P?=?.009) and was perceived to be more comfortable by both blinded caregivers and nurses (caregivers: 84% for the lorazepam?+?haloperidol group vs 37% for the placebo?+?haloperidol group; mean difference, 47% [95% CI, 14% to 73%], P?=?.007; nurses: 77% for the lorazepam?+?haloperidol group vs 30% for the placebo?+?haloperidol group; mean difference, 47% [95% CI, 17% to 71%], P?=?.005). No significant between-group differences were found in delirium-related distress and survival. The most common adverse effect was hypokinesia (3 patients in the lorazepam?+?haloperidol group [19%] and 4 patients in the placebo?+?haloperidol group [27%]).In this preliminary trial of hospitalized patients with agitated delirium in the setting of advanced cancer, the addition of lorazepam to haloperidol compared with haloperidol alone resulted in a significantly greater reduction in agitation at 8 hours. Further research is needed to assess generalizability and adverse effects.clinicaltrials.gov Identifier: NCT01949662.

Project description:ObjectivesFocused research on pediatric agitation is lacking despite being a common mental and behavioral health (MBH) emergency. Prevalence of pediatric agitation remains unknown, and prior reports may have underestimated the rate of restraint use for pediatric agitation. This is the largest study to provide a focused evaluation of the prevalence and predictors of pediatric agitation and restraint use as well as the emergency department (ED) length of stay (LOS) and admission rates for agitated patients.MethodsWe reviewed records of patients aged ≤18 years with MBH needs who visited the pediatric ED of a tertiary care hospital during a 3-year-period. We identified and ascertained agitated/aggressive patients using documented signs/symptoms, International Classification of Diseases, Tenth Revision codes, and Behavioral Activity Rating Scale scores. We performed descriptive and multivariable analyses using SAS 9.4 (SAS Institute).ResultsOf 10,172 patients with MBH needs, 1408 (13.8%) were agitated/aggressive. Of these (n = 1408), 63.7% were boys, and the mean age was 11.9 years. Among agitated patients, the prevalence of restraint use was 28.7%, with a predominance of pharmacologic restraint with atypical antipsychotics. Non-Hispanic Blacks were more likely to be agitated (adjusted odd ratio [aOR], 1.8; 95% CI, 1.2-2.7), but not restrained (aOR, 0.8; 95% CI, 0.3-1.8). Predictors of restraint use include history of attention deficit hyperactivity disorder (aOR, 2.2; 95% CI, 1.5-3.3), autism (aOR, 2.9; 95% CI, 1.9-4.5), conduct disorder (aOR, 1.7; 95% CI, 1.2-2.5), psychosis (aOR, 14.3; 95% CI, 2.5-271.8), and substance use/overdose states (aOR, 1.9; CI, 1.2-3.2). Restrained agitated patients had longer ED LOS (8.4 vs 5.0 hours; P < 0.0001) and higher admission rates (aOR, 2.6; 95% CI, 2.0-3.5). Depression (aOR, 0.4; 95% CI, 0.3-0.5) and suicidality (aOR, 0.2; 95% CI, 0.1-0.3) were protective against agitation and restraint use.ConclusionPrevalence of acute agitation and restraint use in pediatric EDs may be much higher than previously reported. Predictors of acute agitation and restraint use among MBH patients were consistent with prior reports. Restrained agitated patients had longer ED LOS and higher admission rates.

Project description:Mental health patients boarding for long hours, even days, in United States emergency departments (EDs) awaiting transfer for psychiatric services has become a considerable and widespread problem. Past studies have shown average boarding times ranging from 6.8 hours to 34 hours. Most proposed solutions to this issue have focused solely on increasing available inpatient psychiatric hospital beds, rather than considering alternative emergency care designs that could provide prompt access to treatment and might reduce the need for many hospitalizations. One suggested option has been the "regional dedicated emergency psychiatric facility," which serves to evaluate and treat all mental health patients for a given area, and can accept direct transfers from other EDs. This study sought to assess the effects of a regional dedicated emergency psychiatric facility design known at the "Alameda Model" on boarding times and hospitalization rates for psychiatric patients in area EDs.Over a 30-day period beginning in January 2013, 5 community hospitals in Alameda County, California, tracked all ED patients on involuntary mental health holds to determine boarding time, defined as the difference between when they were deemed stable for psychiatric disposition and the time they were discharged from the ED for transfer to the regional psychiatric emergency service. Patients were also followed to determine the percentage admitted to inpatient psychiatric units after evaluation and treatment in the psychiatric emergency service.In a total sample of 144 patients, the average boarding time was approximately 1 hour and 48 minutes. Only 24.8% were admitted for inpatient psychiatric hospitalization from the psychiatric emergency service.The results of this study indicate that the Alameda Model of transferring patients from general hospital EDs to a regional psychiatric emergency service reduced the length of boarding times for patients awaiting psychiatric care by over 80% versus comparable state ED averages. Additionally, the psychiatric emergency service can provide assessment and treatment that may stabilize over 75% of the crisis mental health population at this level of care, thus dramatically alleviating the demand for inpatient psychiatric beds. The improved, timely access to care, along with the savings from reduced boarding times and hospitalization costs, may well justify the costs of a regional psychiatric emergency service in appropriate systems.

Dataset Information

Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon).

Publications

Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon).

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