Publications by authors named "Mark G Roback"

Study Objectives: We wished to assess the frequency of critical and high-risk adverse events when ketamine is administered for emergency department (ED) procedural sedation in children and to identify clinical predictors of such adverse events.

Methods: We studied 20 years of sedation encounters from the Pediatric Sedation Research Consortium registry. We descriptively report the frequencies of critical and high-risk adverse events and evaluate their associations with clinical variables.

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Objective: Children with autism spectrum disorder (ASD) often have comorbidities predisposing them to higher risk for sedation-related adverse events (AEs). Our objective was to compare sedation-related AEs in children with and without ASD.

Patients And Methods: We conducted a multicenter study of children aged 3-18 years with and without ASD who underwent sedation outside the operating room from May 1, 2022, to April 30, 2023, using the Pediatric Sedation Research Consortium database.

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Article Synopsis
  • Procedural sedation lacks standardized competencies and training programs across various practitioners and settings, leading to inconsistency in practices.
  • The International Committee for the Advancement of Procedural Sedation aimed to establish a consensus on the essential competencies required for practitioners, utilizing a framework focused on Competency-Based Medical Education.
  • Through literature review and iterative consensus-building, the committee identified core competencies related to knowledge, skills, and attitudes, and proposed a structured framework for training and credentialing in procedural sedation.
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Objectives: Relatively little is known about outcomes of procedural sedation in very young children. Our objective was to examine the association between procedural sedation in young children (≤ 2 years) and the incidence of sedation-related adverse events.

Methods: This is a secondary analysis of a prospective cohort study of children 0 to 18 years undergoing parenteral procedural sedation in six Canadian pediatric emergency departments (ED).

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As currently written, national regulatory guidance on procedural sedation has elements that are contradictory, confusing, and out of date. As a result, hospital procedural sedation policies are often widely inconsistent between institutions despite similar settings and resources, putting emergency department (ED) patients at risk by denying them uniform access to safe, effective, and appropriate procedural sedation care. Many hospitals have chosen to take overly conservative stances with respect to regulatory compliance to minimize their perceived risk.

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Introduction: Direct hospital admission of children without evaluation in the emergency department (ED) is common, but few guidelines exist to maximize safety by assessing patient stability. This report describes a novel approach to support patient safety.

Methods: An interdisciplinary children's hospital team developed a brief ED-based evaluation process called the ED Rapid Assessment of Patients Intended for Inpatient Disposition (ED RAPID).

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Autism spectrum disorder (ASD) affects more than 1% of children in the United States, with the rate of new diagnoses climbing significantly in the last 15 years. Emergent conditions and subsequent visits to the emergency department (ED) can be particularly challenging for children with ASD, most of whom also have comorbidities in addition to their deficits in social communication and interaction. In the emergency setting, these conditions can cause a range of behaviors that result in challenges for health care providers and may result in suboptimal experiences for children with ASD and their families.

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Objectives: Our primary objective was to describe emergency department (ED) presentation, treatment, and outcomes for children after hematopoietic cell transplantation (HCT). Our secondary objective was to identify factors associated with serious infection in this population.

Methods: This is a retrospective review of HCT patients who presented to our university children's hospital ED from January 1, 2011, to June 30, 2013.

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Background: The risk of respiratory depression is increased when opioids are added to sedative agents. In our recent multicenter emergency department (ED) procedural sedation cohort, we reported a strong association between preprocedural opioids and sedation-related adverse events. We sought to examine the association between timing of opioids and the incidence of adverse sedation outcomes.

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: The incidence of sedation-related adverse events, inclusive of both adults and children, administered by multiple specialty providers from different countries and venues, using standardized definitions, has never been reported on an international level. We are reporting the outcome data of the adverse event sedation reporting tool as an important step toward a more complete risk assessment of sedation-related morbidity, mortality, and etiology. The analysis of the AE sedation reporting data include descriptive measures to evaluate the characteristics of the provider, the patient, sedations performed, adverse events, interventions, and outcomes.

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The American College of Emergency Physicians (ACEP) organized a multidisciplinary effort to create a clinical practice guideline specific to unscheduled, time-sensitive procedural sedation, which differs in important ways from scheduled, elective procedural sedation. The purpose of this guideline is to serve as a resource for practitioners who perform unscheduled procedural sedation regardless of location or patient age. This document outlines the underlying background and rationale, and issues relating to staffing, practice, and quality improvement.

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Objectives: To describe inpatient management of patients with croup admitted from the emergency department (ED).

Methods: In a multicentered, cross-sectional observational study based on retrospective chart review, we identified children 6 months to 5 years of age with a discharge diagnosis of croup. All patients were evaluated in the ED and treated with at least 1 dose of racemic epinephrine (RE) before admission.

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We review the literature in regard to the accuracy, reliability, and feasibility of the Mallampati score as might be pertinent and applicable to emergency department (ED) airway management and procedural sedation. This 4-level pictorial tool was devised to predict difficult preoperative laryngoscopy and intubation, but is now also widely recommended as a routine screening element before procedural sedation. The literature evidence demonstrates that the Mallampati score is inadequately sensitive for the identification of difficult laryngoscopy, difficult intubation, and difficult bag-valve-mask ventilation, with likelihood ratios indicating a small and clinically insignificant effect on outcome prediction.

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Background And Objectives: Children with autism spectrum disorder (ASD) present more frequently to the emergency department (ED) than children with normal development, and frequently have injuries requiring procedural sedation. Our objective was to describe sedation practice and outcomes in children with ASD in the ED.

Methods: We performed a retrospective chart review of children with ASD who underwent sedation at two tertiary care EDs between January 2009-December 2016.

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Background: Novel interventions for treatment-resistant depression (TRD) in adolescents are urgently needed. Ketamine has been studied in adults with TRD, but little information is available for adolescents. This study investigated efficacy and tolerability of intravenous ketamine in adolescents with TRD, and explored clinical response predictors.

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Importance: It is not clear whether adherence to preprocedural fasting guidelines prevent pulmonary aspiration and associated adverse outcomes during emergency department (ED) sedation of children.

Objective: To examine the association between preprocedural fasting duration and the incidence of sedation-related adverse outcomes in a large sample of children.

Design, Setting, And Participants: We conducted a planned secondary analysis of a multicenter prospective cohort study of children aged 0 to 18 years who received procedural sedation for a painful procedure in 6 Canadian pediatric EDs from July 2010 to February 2015.

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The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm.

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Objectives: This study aims to evaluate frequency, type, and cost of gastrostomy tube (GT) versus gastrojejunostomy tube (GJT) complications in children presenting to the emergency department (ED).

Methods: Patients were selected by electronic health record search for International Classification of Diseases, Ninth Revision, and procedure codes for GTs and GJTs/jejunostomy tubes. All children aged less than 18 years with GTs or GJTs placed during a 5-year period (2007-2012) at the University of Minnesota Masonic Children's Hospital were identified for retrospective review.

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Importance: Procedural sedation for children undergoing painful procedures is standard practice in emergency departments worldwide. Previous studies of emergency department sedation are limited by their single-center design and are underpowered to identify risk factors for serious adverse events (SAEs), thereby limiting their influence on sedation practice and patient outcomes.

Objective: To examine the incidence and risk factors associated with sedation-related SAEs.

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Objectives: Outcomes associated with a sedative regimen comprised ketamine + propofol for pediatric procedural sedation outside of both the pediatric emergency department and operating room are underreported. We used the Pediatric Sedation Research Consortium database to describe a multicenter experience with ketamine + propofol by pediatric sedation providers.

Design: Prospective observational study of children receiving IV ketamine + propofol for procedural sedation outside of the operating room and emergency department using data abstracted from the Pediatric Sedation Research Consortium during 2007-2015.

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Objective: Most studies of ketamine administered to children for procedural sedation are limited to emergency department use. The objective of this study was to describe the practice of ketamine procedural sedation outside of the operating room and identify risk factors for adverse events.

Design: Observational cohort review of data prospectively collected from 2007 to 2015 from the multicenter Pediatric Sedation Research Consortium.

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Children often require transfer to pediatric hospital emergency departments (EDs) after evaluation in community hospital EDs. Such transfers are regulated by the federal Emergency Medical Treatment and Labor Act. Unusual circumstances, such as logistical errors in the physical transfer of the patient, may increase Emergency Medical Treatment and Labor Act-related liability risks for hospitals and ED physicians.

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