Prehospital Agitation and Sedation Trial (PhAST): A Randomized Control Trial of Intramuscular Haloperidol versus Intramuscular Midazolam for the Sedation of the Agitated or Violent Patient in the Prehospital Environment

Isenberg, Derek; Jacobs, Dorian

doi:10.1017/s1049023x15004999

Cited by 34 publications

(19 citation statements)

References 22 publications

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“…There was no standard way of measuring or reporting AEs (see Table 4). The frequency of AE differed between studies (ranging from 0% (Bieniek et al 1998;Dorevitch et al 1999;Isenberg & Jacobs 2015;Rosen et al 1997) to 38.1% (Asodollahi et al 2015)).…”

Section: Interventionsmentioning

confidence: 99%

The effectiveness of chemical restraint in managing acute agitation and aggression: A systematic review of randomized controlled trials

Muir‐Cochrane

Oster

Gerace

et al. 2019

Int J Mental Health Nurs

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One approach to manage people with behaviours of concern including agitated or aggressive behaviours in health care settings is through the use of fast‐acting medication, called chemical restraint. Such management often needs to be delivered in crisis situations to patients who are at risk of harm to themselves or others. This paper summarizes the available evidence on the effectiveness and safety of chemical restraint from 21 randomized controlled trials (RCTs) involving 3788 patients. The RCTs were of moderate to high quality and were conducted in pre‐hospital, hospital emergency department, or ward settings. Drugs used in chemical restraint included olanzapine, haloperidol, droperidol, risperidol, flunitrazepam, midazolam, promethazine, ziprasidone, sodium valproate, or lorazepam. There was limited comparability between studies in drug choice, combination, dose, method of administration (oral, intramuscular, or intravenous drip), or timing of repeat administrations. There were 31 outcome measures, which were inconsistently reported. They included subjective measures of behaviours, direct measures of treatment effect (time to calm; time to sleep), indirect measures of agitation (staff or patient injuries, duration of agitative or aggressive episodes, subsequent violent episodes), and adverse events. The most common were time to calm and adverse events. There was little clarity about the superiority of any chemical method of managing behaviours of concern exhibited by patients in Emergency Departments or acute mental health settings. Not only is more targeted research essential, but best practice recommendations for such situations requires integrating expert input into the current evidence base.

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Section: Interventionsmentioning

confidence: 99%

The effectiveness of chemical restraint in managing acute agitation and aggression: A systematic review of randomized controlled trials

Muir‐Cochrane

Oster

Gerace

et al. 2019

Int J Mental Health Nurs

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“…In July 2017, the FDA issued guidance that until such regulations are finalized, FDA does not intend to object to a local IRB approving a waived consent study when the IRB finds and documents that traditional WIC criteria have been met (see Table ) . To our knowledge no such trial has yet been conducted under this new FDA authority, although one small randomized trial of midazolam versus haloperidol for prehospital agitation was conducted under WIC criteria prior to passage of the 21st Century Cures Act …”

Section: Discussionmentioning

confidence: 99%

Study Enrollment When “Preconsent” Is Utilized for a Randomized Clinical Trial of Two Treatments for Acute Agitation in the Emergency Department

Cole

Klein

Mullinax

et al. 2019

Academic Emergency Medicine

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Background: Acute agitation in the emergency department (ED) represents a danger to both patients and their caregivers. Medication is often needed, and few high-quality randomized trials have evaluated the optimal drugs for this vulnerable population. In the United States, as of 2017, randomized trials of drugs typically cannot be conducted under Waiver of Consent (46 CFR 45.116), and Exception From Informed Consent trials (21 CFR 50.24) are limited to life-threatening conditions, are onerous, and require filing an investigational new drug application with the FDA. We sought to conduct a randomized double-dummy trial of inhaled loxapine versus intramuscular haloperidol + lorazepam for acute agitation in the ED by obtaining consent in advance ("preconsent") in patients at risk of future agitation, allowing study drug administration up to 3 years later if the patient presented with acute agitation.Objective: We sought to report the successful enrollment rate of patients preconsented at an earlier ED visit for this trial.Methods: This was an analysis of patients age 18 to 64 with bipolar I disorder or schizophrenia preconsented for enrollment in the trial (clinicaltrials.gov, NCT02877108) conducted at a single urban academic center seeing approximately 60,000 patients per year. Eligible patients were assessed for capacity to consent by trained research associates, and informed consent was obtained at an ED visit for the possibility of administering drugs for agitation within the next 3 years. In the event the patient later presented to the ED and the attending physician deemed the patient required treatment for acute agitation, preconsent was confirmed and study drug would be administered.Results: Over 67 days, 1,461 patients were screened in the ED, 269 had bipolar I or schizophrenia, 194 of whom had a contraindication to inhaled loxapine leaving 75 eligible patients; preconsent was obtained in 43 patients. Four additional patients who had not preconsented were consented for the trial in real time (three by surrogate, one patient had capacity while agitated) resulting in a total of 47 consented patients. Of these 47, a total of 12 were later removed from the study: 10 patients had unrecognized exclusion criteria for inhaled

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“…In relation to pharmacologic management, current prehospital treatments are based on the ED’s practices, although sedating agitated patients in the ED differs significantly from sedation in a prehospital environment. 6 , 7 , 15 , 16 Parenteral benzodiazepines, and first- and second-generation antipsychotics, alone or in combination, are primarily used because of their sedative effects and rapid onset of action. Intramuscular (IM) ketamine and intranasal midazolam have also been used as good sedative options.…”

Section: Discussionmentioning

confidence: 99%

Inhaled Loxapine for the Treatment of Psychiatric Agitation in the Prehospital Setting: A Case Series

Cester-Martínez¹,

Cortés-Ramas²,

Borraz-Clares³

et al. 2017

CPC-EM

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Rapid and effective control of agitated patients is crucial for ensuring their safety and proper management. We present a case series of 12 agitated psychiatric patients who were suitable for treatment with inhaled loxapine in the prehospital emergency setting. Two refused its administration and two required additional treatment. Loxapine was effective within 2–10 minutes, with no adverse effects or sedation. In our experience the use of inhaled loxapine enabled rapid and non-coercive control of agitation in most psychiatric patients, allowing us to avoid mechanical restraint and injectable drugs, and facilitating the transportation and transfer of the patients.

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Prehospital Agitation and Sedation Trial (PhAST): A Randomized Control Trial of Intramuscular Haloperidol versus Intramuscular Midazolam for the Sedation of the Agitated or Violent Patient in the Prehospital Environment

Cited by 34 publications

References 22 publications

The effectiveness of chemical restraint in managing acute agitation and aggression: A systematic review of randomized controlled trials

The effectiveness of chemical restraint in managing acute agitation and aggression: A systematic review of randomized controlled trials

Study Enrollment When “Preconsent” Is Utilized for a Randomized Clinical Trial of Two Treatments for Acute Agitation in the Emergency Department

Inhaled Loxapine for the Treatment of Psychiatric Agitation in the Prehospital Setting: A Case Series

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