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Journal of the American College of... Oct 2020Agitated patients presenting to the emergency department (ED) can escalate to aggressive and violent behaviors with the potential for injury to themselves, ED staff, and... (Review)
Review
Improving the management of acutely agitated patients in the emergency department through implementation of Project BETA (Best Practices in the Evaluation and Treatment of Agitation).
Agitated patients presenting to the emergency department (ED) can escalate to aggressive and violent behaviors with the potential for injury to themselves, ED staff, and others. Agitation is a nonspecific symptom that may be caused by or result in a life-threatening condition. Project BETA (Best Practices in the Evaluation and Treatment of Agitation) is a compilation of the best evidence and consensus recommendations developed by emergency medicine and psychiatry experts in behavioral emergencies to improve our approach to the acutely agitated patient. These recommendations focus on verbal de-escalation as a first-line treatment for agitation; pharmacotherapy that treats the most likely etiology of the agitation; appropriate psychiatric evaluation and treatment of associated medical conditions; and minimization of physical restraint/seclusion. Implementation of Project BETA in the ED can improve our ability to manage a patient's agitation and reduce the number of physical assaults on ED staff. This article summarizes the BETA guidelines and recent supporting literature for managing the acutely agitated patient in the ED followed by a discussion of how a large county hospital integrated these recommendations into daily practice.
PubMed: 33145538
DOI: 10.1002/emp2.12138 -
Pediatric Research Aug 2020Preterm infants are exposed to frequent painful procedures and agitating stimuli over the many weeks of their hospitalization in the neonatal intensive care unit (NICU).... (Review)
Review
Preterm infants are exposed to frequent painful procedures and agitating stimuli over the many weeks of their hospitalization in the neonatal intensive care unit (NICU). The adverse neurobiological impact of pain and stress in the preterm infant has been well documented, including neuroimaging and neurobehavioral outcomes. Although many tools have been validated to assess acute pain, few methods are available to assess chronic pain or agitation (a clinical manifestation of neonatal stress). Both nonpharmacologic and pharmacologic approaches are used to reduce the negative impact of pain and agitation in the preterm infant, with concerns emerging over the adverse effects of analgesia and sedatives. Considering benefits and risks of available treatments, units must develop a stepwise algorithm to prevent, assess, and treat pain. Nonpharmacologic interventions should be consistently utilized prior to mild to moderately painful procedures. Sucrose may be utilized judiciously as an adjunctive therapy for minor painful procedures. Rapidly acting opioids (fentanyl or remifentanil) form the backbone of analgesia for moderately painful procedures. Chronic sedation during invasive mechanical ventilation represents an ongoing challenge; appropriate containment and an optimal environment should be standard; when indicated, low-dose morphine infusion may be utilized cautiously and dexmedetomidine infusion may be considered as an emerging adjunct.
Topics: Algorithms; Analgesics, Opioid; Brain; Chronic Pain; Dexmedetomidine; Fentanyl; Humans; Hypnotics and Sedatives; Infant; Infant, Newborn; Infant, Premature; Intensive Care Units, Neonatal; Morphine; Neuroimaging; Pain; Pain Management; Remifentanil; Respiration, Artificial; Stress, Psychological; Sucrose
PubMed: 31896130
DOI: 10.1038/s41390-019-0744-6 -
The Western Journal of Emergency... Mar 2019Agitation in children and adolescents in the emergency department (ED) can be dangerous and distressing for patients, family and staff. We present consensus guidelines...
Best Practices for Evaluation and Treatment of Agitated Children and Adolescents (BETA) in the Emergency Department: Consensus Statement of the American Association for Emergency Psychiatry.
INTRODUCTION
Agitation in children and adolescents in the emergency department (ED) can be dangerous and distressing for patients, family and staff. We present consensus guidelines for management of agitation among pediatric patients in the ED, including non-pharmacologic methods and the use of immediate and as-needed medications.
METHODS
Using the Delphi method of consensus, a workgroup comprised of 17 experts in emergency child and adolescent psychiatry and psychopharmacology from the the American Association for Emergency Psychiatry and the American Academy of Child and Adolescent Psychiatry Emergency Child Psychiatry Committee sought to create consensus guidelines for the management of acute agitation in children and adolescents in the ED.
RESULTS
Consensus found that there should be a multimodal approach to managing agitation in the ED, and that etiology of agitation should drive choice of treatment. We describe general and specific recommendations for medication use.
CONCLUSION
These guidelines describing child and adolescent psychiatry expert consensus for the management of agitation in the ED may be of use to pediatricians and emergency physicians who are without immediate access to psychiatry consultation.
Topics: Adolescent; Child; Consensus; Disease Management; Emergency Medical Services; Humans; Practice Guidelines as Topic; Psychiatry; Psychomotor Agitation; United States
PubMed: 30881565
DOI: 10.5811/westjem.2019.1.41344 -
The Cochrane Database of Systematic... Apr 2017Aggression is a disposition, a willingness to inflict harm, regardless of whether this is behaviourally or verbally expressed and regardless of whether physical harm is... (Review)
Review
BACKGROUND
Aggression is a disposition, a willingness to inflict harm, regardless of whether this is behaviourally or verbally expressed and regardless of whether physical harm is sustained.De-escalation is a psychosocial intervention for managing people with disturbed or aggressive behaviour. Secondary management strategies such as rapid tranquillisation, physical intervention and seclusion should only be considered once de-escalation and other strategies have failed to calm the service user.
OBJECTIVES
To investigate the effects of de-escalation techniques in the short-term management of aggression or agitation thought or likely to be due to psychosis.
SEARCH METHODS
We searched Cochrane Schizophrenia Group's Study-Based Register of Trials (latest search 7 April, 2016).
SELECTION CRITERIA
Randomised controlled trials using de-escalation techniques for the short-term management of aggressive or agitated behaviour. We planned to include trials involving adults (at least 18 years) with a potential for aggressive behaviour due to psychosis, from those in a psychiatric setting to those possibly under the influence of alcohol or drugs and/or as part of an acute setting as well. We planned to include trials meeting our inclusion criteria that provided useful data.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Two review authors inspected all abstracts of studies identified by the search process. As we were unable to include any studies, we could not perform data extraction and analysis.
MAIN RESULTS
Of the 345 citations that were identified using the search strategies, we found only one reference to be potentially suitable for further inspection. However, after viewing the full text, it was excluded as it was not a randomised controlled trial.
AUTHORS' CONCLUSIONS
Using de-escalation techniques for people with psychosis induced aggression or agitation appears to be accepted as good clinical practice but is not supported by evidence from randomised trials. It is unclear why it has remained such an under-researched area. Conducting trials in this area could be influenced by funding flow, ethical concerns - justified or not - anticipated pace of recruitment as well the difficulty in accurately quantifying the effects of de-escalation itself. With supportive funders and ethics committees, imaginative trialists, clinicians and service-user groups and wide collaboration this dearth of randomised research could be addressed.
Topics: Aggression; Behavior Control; Crisis Intervention; Humans; Psychomotor Agitation; Psychotic Disorders
PubMed: 28368091
DOI: 10.1002/14651858.CD009922.pub2 -
JAMA Neurology Dec 2023Agitation is a prevalent, distressing, and burdensome manifestation of Alzheimer dementia in need of an efficacious, safe, and well-tolerated treatment.
IMPORTANCE
Agitation is a prevalent, distressing, and burdensome manifestation of Alzheimer dementia in need of an efficacious, safe, and well-tolerated treatment.
OBJECTIVE
To confirm the efficacy, safety, and tolerability of brexpiprazole in patients with agitation in Alzheimer dementia.
DESIGN, SETTING, AND PARTICIPANTS
This randomized clinical trial was a 12-week, double-blind, placebo-controlled, fixed-dose, parallel-arm trial that ran from May 2018 to June 2022 at 123 clinical trial sites in Europe and the United States. Participants included patients with agitation in Alzheimer dementia in a care facility or community-based setting. Stable Alzheimer disease medications were permitted.
INTERVENTIONS
In this 2-arm trial, patients were randomized to receive oral brexpiprazole or placebo (2:1 ratio) for 12 weeks. Within the brexpiprazole arm, patients were further randomized to receive fixed doses of 2 mg/d or 3 mg/d in a 1:2 ratio.
MAIN OUTCOMES AND MEASURES
The primary end point was change in Cohen-Mansfield Agitation Inventory total score (which measures the frequency of 29 agitated behaviors) from baseline to week 12 for brexpiprazole, 2 or 3 mg, vs placebo. Safety was assessed by standard measures, including treatment-emergent adverse events.
RESULTS
A total of 345 patients were randomized to receive brexpiprazole (n = 228) or placebo (n = 117); completion rates were 198 (86.8%) for brexpiprazole and 104 (88.9%) for placebo. Mean (SD) age was 74.0 (7.5) years, and 195 of 345 patients were female (56.5%). Patients receiving brexpiprazole, 2 or 3 mg (n = 225), demonstrated statistically significantly greater improvement than those taking placebo (n = 116) in Cohen-Mansfield Agitation Inventory total score from baseline to week 12 (brexpiprazole baseline, 80.6, mean change, -22.6; placebo baseline, 79.2, mean change, -17.3; least-squares mean difference, -5.32; 95% CI, -8.77 to -1.87; P = .003; Cohen d effect size, 0.35). No treatment-emergent adverse events had an incidence of 5% or more with brexpiprazole and greater incidence than placebo. The proportion of patients who discontinued because of adverse events was 12 of 226 (5.3%) for brexpiprazole and 5 of 116 (4.3%) for placebo.
CONCLUSIONS AND RELEVANCE
In this study, patients with Alzheimer dementia who took brexpiprazole, 2 or 3 mg, showed a statistically significant improvement vs placebo in agitation over 12 weeks. Brexpiprazole was generally well tolerated over 12 weeks in this vulnerable patient population.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03548584.
Topics: Humans; Female; Aged; Male; Alzheimer Disease; Aggression; Double-Blind Method; Treatment Outcome
PubMed: 37930669
DOI: 10.1001/jamaneurol.2023.3810 -
Journal of the American Medical... Jul 2022To test the effect of a personalized music intervention on agitated behaviors and medication use among long-stay nursing home residents with dementia. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To test the effect of a personalized music intervention on agitated behaviors and medication use among long-stay nursing home residents with dementia.
DESIGN
Pragmatic, cluster-randomized controlled trial of a personalized music intervention. Staff in intervention facilities identified residents' early music preferences and offered music at early signs of agitation or when disruptive behaviors typically occur. Usual care in control facilities may include ambient or group music.
SETTING AND PARTICIPANTS
The study was conducted between June 2019 and February 2020 at 54 nursing homes (27 intervention and 27 control) in 10 states owned by 4 corporations.
METHODS
Four-month outcomes were measured for each resident. The primary outcome was frequency of agitated behaviors using the Cohen-Mansfield Agitation Inventory. Secondary outcomes included frequency of agitated behaviors reported in the Minimum Data Set and the proportion of residents using antipsychotic, antidepressant, or antianxiety medications.
RESULTS
The study included 976 residents with dementia [483 treatment and 493 control; mean age = 80.3 years (SD 12.3), 69% female, 25% African American]. CMAI scores were not significantly different (treatment: 50.67, SE 1.94; control: 49.34, SE 1.68) [average marginal effect (AME) 1.33, SE 1.38, 95% CI -1.37 to 4.03]. Minimum Data Set-based behavior scores were also not significantly different (treatment: 0.35, SE 0.13; control: 0.46, SE 0.11) (AME -0.11, SE 0.10, 95% CI -0.30 to 0.08). Fewer residents in intervention facilities used antipsychotics in the past week compared with controls (treatment: 26.2, SE 1.4; control: 29.6, SE 1.3) (AME -3.61, SE 1.85, 95% CI -7.22 to 0.00), but neither this nor other measures of psychotropic drug use were statistically significant.
CONCLUSIONS AND IMPLICATIONS
Personalized music was not significantly effective in reducing agitated behaviors or psychotropic drug use among long-stay residents with dementia. Barriers to full implementation included engaging frontline nursing staff and identifying resident's preferred music.
Topics: Aged, 80 and over; Antidepressive Agents; Antipsychotic Agents; Dementia; Female; Humans; Male; Nursing Homes; Psychomotor Agitation
PubMed: 35038407
DOI: 10.1016/j.jamda.2021.12.030 -
BMJ Open Jul 2019The aim of this systematic review was to assess the efficacy and safety of pharmacological agents in the management of agitated behaviours following traumatic brain...
OBJECTIVE
The aim of this systematic review was to assess the efficacy and safety of pharmacological agents in the management of agitated behaviours following traumatic brain injury (TBI).
METHODS
We performed a search strategy in PubMed, OvidMEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, Google Scholar, Directory of Open Access Journals, LILACS, Web of Science and Prospero (up to 10 December 2018) for published and unpublished evidence on the risks and benefits of 9 prespecified medications classes used to control agitated behaviours following TBI. We included all randomised controlled trials, quasi-experimental and observational studies examining the effects of medications administered to control agitated behaviours in TBI patients. Included studies were classified into three mutually exclusive categories: (1) agitated behaviour was the presenting symptom; (2) agitated behaviour was not the presenting symptom, but was measured as an outcome variable; and (3) safety of pharmacological interventions administered to control agitated behaviours was measured.
RESULTS
Among the 181 articles assessed for eligibility, 21 studies were included. Of the studies suggesting possible benefits, propranolol reduced maximum intensities of agitation per week and physical restraint use, methylphenidate improved anger measures following 6 weeks of treatment, valproic acid reduced weekly agitated behaviour scale ratings and olanzapine reduced irritability, aggressiveness and insomnia between weeks 1 and 3 of treatment. Amantadine showed variable effects and may increase the risk of agitation in the critically ill. In three studies evaluating safety outcomes, antipsychotics were associated with an increased duration of post-traumatic amnesia (PTA) in unadjusted analyses. Small sample sizes, heterogeneity and an unclear risk of bias were limits.
CONCLUSIONS
Propranolol, methylphenidate, valproic acid and olanzapine may offer some benefit; however, they need to be further studied. Antipsychotics may increase the length of PTA. More studies on tailored interventions and continuous evaluation of safety and efficacy throughout acute, rehabilitation and outpatient settings are needed.
PROSPERO REGISTRATION NUMBER
CRD42016033140.
Topics: Antipsychotic Agents; Brain Injuries, Traumatic; Humans; Psychomotor Agitation; Psychoses, Substance-Induced; Randomized Controlled Trials as Topic
PubMed: 31289093
DOI: 10.1136/bmjopen-2019-029604 -
Lancet (London, England) Oct 2021Agitation 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... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Agitation 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.
METHODS
This 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.
FINDINGS
Between 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).
INTERPRETATION
This 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.
FUNDING
UK National Institute for Health Research Health Technology Assessment Programme.
Topics: Aged, 80 and over; Anti-Anxiety Agents; Brief Psychiatric Rating Scale; Caregivers; Dementia; Double-Blind Method; Female; Humans; Male; Mirtazapine; Psychomotor Agitation; Quality of Life; United Kingdom
PubMed: 34688369
DOI: 10.1016/S0140-6736(21)01210-1 -
The Lancet. Oncology Jul 2020The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with... (Randomized Controlled Trial)
Randomized Controlled Trial
Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial.
BACKGROUND
The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium.
METHODS
In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1 mg and chlorpromazine at 12·5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov, NCT03021486.
FINDINGS
Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3 [-4·4 to -2·2]), and combination group (n=10, -3·0 [-4·6 to -1·4]), with no difference among groups (p=0·71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths.
INTERPRETATION
Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group.
FUNDING
National Institute of Nursing Research.
Topics: Aged; Antipsychotic Agents; Delirium; Double-Blind Method; Female; Follow-Up Studies; Haloperidol; Humans; Male; Middle Aged; Neoplasms; Palliative Care; Prognosis; Psychomotor Agitation
PubMed: 32479786
DOI: 10.1016/S1470-2045(20)30307-7