Regulatory Challenges to Emergency Medicine Procedural Sedation.

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written, national regulatory guidance on procedural sedation has elements that are contradictory, confusing, and out of date.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. Herein, we review and critique standards and policies from the Centers for Medicare & Medicaid Services, The Joint Commission, state nursing boards, the Food and Drug Administration, and others with respect to their effect on ED procedural sedation. Where appropriate, we recommend modifications of and enhancements to their guidance that would improve the access of ED patients to modern, safe, and effective procedural sedation care.

Impact of young age on outcomes of emergency department procedural sedation.

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). The primary risk factor was age ≤ 2 years. Secondary risk factors were sex, procedure type, pre-procedure and sedation medications. The outcomes examined were: serious adverse events (SAE), significant interventions, oxygen desaturation and vomiting. RESULTS: Of the 6295 patients included, 946 (15%) were ≤2 years. Children 13-24 months comprised 90% of the young age group. Children ≤ 2 years were sedated most commonly for laceration repair (n = 450; 47.6%), while orthopedic reduction was most common in children > 2 (n = 3983; 74.5%). Ketamine was the most common medication in both groups, but was used more frequently in children ≤ 2 years (80.9% vs 58.9%; p < 0.001). There was no difference in the odds of SAE (OR 0.83, 95% Confidence Interval (CI) 0.4 to 1.9), significant intervention (OR 0.82, 95% CI 0.4 to 1.7) or oxygen desaturation (OR 0.95, 95% CI 0.7 to 1.3) between age groups, however children ≤ 2 years vomited less frequently (OR 0.24, 95% CI 0.1 to 0.6). CONCLUSIONS: Young age, specifically between 13 and 24 months, was not associated with a significant difference in the incidence of adverse events.

Case Studies of Challenges in Emergency Care for Children With Autism Spectrum Disorder.

ABSTRACT: 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. We present the ED course of 3 children with ASD to illustrate these challenges, emphasize successful strategies, and highlight opportunities for improvement.

Outcomes of Children Who Present to the Emergency Department After Hematopoietic Cell Transplantation.

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. Emergency department presentation, treatment, and outcomes were described. Descriptive statistics were used to compare children with definite serious infection with those without serious infection. Multiple binary logistic regression was performed for risk factors associated with definite serious infection. RESULTS: Fifty-four HCT patients (132 encounters) presented to our ED. Most were transplanted for a malignant (46%) or metabolic (36%) diagnosis and were recipients of bone marrow (51%) or umbilical cord blood (45%). Fever was the most common complaint (25%). Emergency department laboratory (64%) or imaging (58%) studies were frequently obtained. Admission was common (n = 70/132, 53%), with 79% (n = 55) of admissions to intensive care or bone marrow transplant units. Thirty-five encounters had definite serious infection, 5 had probable serious infection, and 92 had no serious infection. Fever (P < 0.001) and high-risk white blood cell (WBC) count of less than 5 or greater than 15 k/µL (P < 0.001) were associated with definite serious infection. Fever (odds ratio = 8.84, 95% confidence interval = 2.92-26.73) and high-risk WBC (odds ratio = 6.67, 95% confidence interval = 2.24-19.89) remained significantly associated with definite serious infection in our regression model. CONCLUSIONS: Children presenting to the ED after HCT require extensive support and resources, with more than half requiring admission. Fever and high-risk WBC are associated with serious infection.

Is the Mallampati Score Useful for Emergency Department Airway Management or Procedural Sedation?

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. Although it is important to anticipate that patients may have a difficult airway, there is no specific evidence that the Mallampati score augments or improves the baseline clinical judgment of a standard airway evaluation. It generates numerous false-positive warnings for each correct prediction of a difficult airway. The Mallampati score is not reliably assessed because independent observers commonly grade it differently. It cannot be evaluated in many young children and in patients who cannot cooperate because of their underlying medical condition. The Mallampati score lacks the accuracy, reliability, and feasibility required to supplement a standard airway evaluation before ED airway management or procedural sedation.

Unscheduled Procedural Sedation: A Multidisciplinary Consensus Practice Guideline.

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.

Procedural sedation in children with autism spectrum disorders in the emergency department.

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. Data were collected on children 1-18 years of age with ASD who were sedated in the ED. RESULTS: There were 6020 ED visits by children with ASD, 126 (2.1%) of whom received sedation. The most frequent indications for sedation were laceration repair (24.6%), incision and drainage (17.5%), diagnostic imaging (14.3%), and physical examination (11.9%). The most common sedatives used were ketamine (50.8%) and midazolam (50.8%). Ketamine was most commonly given intravenously (71.9%), while midazolam was usually given intranasally (71.9%). Procedures could not be completed in 4 (3.2%) patients, and adverse events were noted in 23 (18.3%) patients. Only four (3.2%) patients required supplemental oxygenation, and one received positive pressure ventilation. CONCLUSIONS: Children with autism in the ED commonly received sedation; one in four of which were for non-painful diagnostic procedures or physical examination. Over one-third received sedation via a non-parenteral route for intended minimal sedation. Sedative medication dosing and observed adverse events were similar to those reported previously in children without ASD. Emergency providers must be prepared to meet the unique sedation needs of children with ASD.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

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." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report From the Pediatric Sedation Research Consortium.

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. SETTING: Procedural sedation services from academic, community, free-standing children's hospitals, and pediatric wards within general hospitals. PATIENTS: Children from birth to less than or equal to 21 years old. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 7,313 pediatric procedural sedations were performed using IV ketamine + propofol as the primary sedative regimen. Median age was 84 months (range, < 1 mo to ≤ 21 yr; interquartile range, 36-144); 80.6% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedation was performed in dedicated sedation or radiology units (76.1%). Procedures were successfully completed in 99.8% of patients. Anticholinergics (glycopyrrolate and atropine) or benzodiazepines (midazolam and lorazepam) were used in 14.2% and 41.3%, respectively. The overall adverse event and serious adverse event rates were 9.79% (95% CI, 9.12-10.49%) and 3.47% (95% CI, 3.07-3.92%), respectively. No deaths occurred. Risk factors associated with an increase in odds of adverse event included ASA status greater than or equal to III, dental suite, cardiac catheterization laboratory or radiology/sedation suite location, a primary diagnosis of having a gastrointestinal illness, and the coadministration of an anticholinergic. CONCLUSIONS: Using Pediatric Sedation Research Consortium data, we describe the diverse use of IV ketamine + propofol for procedural sedation in the largest reported cohort of children to date. Data from this study may be used to design sufficiently powered prospective randomized, double-blind studies comparing outcomes of sedation between commonly administered sedative and analgesic medication regimens.

Comparison of Emergency Department Visits for Complications of Gastrostomy Versus Gastrojejunostomy Tubes in Children.

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. Comparisons were made on demographic data, number and type of complications, and interventions performed for ED visits, which were abstracted from the electronic health record. Cost data were abstracted from the financial data system. RESULTS: A total of 161 GT and GJT patients were identified; 31 children had 43 ED visits for complications. Ages ranged from 1 month to 17 years; median, 12 months; mean, 5.4 years; 25 (58%) were male, and 18 female (42%). Complications occurred in 15 GT (48.4%) and 16 GJT (51.6%) patients. The most common ED presenting complication was dislodgement, which occurred in 14 GTs (67%) and 18 GJTs (82%), followed by clogging 6 GTs (29%) and 1 GJTs (4.5%). Those presenting to the ED with GJT complications had higher mean overall charge (US $1987.00 vs US $913.10, P = 0.05). CONCLUSIONS: Although GTs and GJTs had similar rates of complications and ED visits, GJT complications were more likely to result in hospital admission and intervention by radiology, require specialist involvement, and have a higher cost charged to the patient.

Procedural Sedation Outside of the Operating Room Using Ketamine in 22,645 Children: A Report From the Pediatric Sedation Research Consortium.

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. SETTING: Sedation services from academic, community, free-standing children's hospitals and pediatric wards within general hospitals. PATIENTS: Children from birth to 21 years old or younger. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Describe patient characteristics, procedure type, and location of administration of ketamine procedural sedation. Analyze sedation-related adverse events and severe adverse events. Identify risk factors for adverse events using multivariable logistic regression. A total of 22,645 sedations performed using ketamine were analyzed. Median age was 60 months (range, < 1 mo to < 22 yr); 72.0% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedations were performed in dedicated sedation or radiology units (64.6%). Anticholinergics, benzodiazepines, or propofol were coadministered in 19.8%, 57.9%, and 35.4%, respectively. The overall adverse event occurrence rate was 7.26% (95% CI, 6.92-7.60%), and the frequency of severe adverse events was 1.77% (95% CI, 1.60-1.94%). Procedures were not completed in 39 of 19,747 patients (0.2%). Three patients experienced cardiac arrest without death, all associated with laryngospasm. CONCLUSIONS: This is a description of a large prospectively collected dataset of pediatric ketamine administration predominantly outside of the operating room. The overall incidence of severe adverse events was low. Risk factors associated with increased odds of adverse events were as follows: cardiac and gastrointestinal disease, lower respiratory tract infection, and the coadministration of propofol and anticholinergics.

Optimal dosing of intravenous ketamine for procedural sedation in children in the ED-a randomized controlled trial.

OBJECTIVE: The objective of the study is to compare need for redosing, sedation efficacy, duration, and adverse events between 3 commonly administered doses of parenteral ketamine in the emergency department (ED). METHODS: We conducted a prospective, double-blind, randomized controlled trial on a convenience sample of children 3 to 18years who received intravenous ketamine for procedural sedation. Children from each age group (3-6, 7-12, and 13-18years) were assigned in equal numbers to 3 dosing groups (1, 1.5, and 2mg/kg) using random permuted blocks. The primary outcome measure was need for ketamine redosing to ensure adequate sedation. Secondary outcome measures were sedation efficacy, sedation duration, and sedation-related adverse events. RESULTS: A total of 171 children were enrolled of whom 125 (1mg/kg, 50; 1.5mg/kg, 35; 2mg/kg, 40) received the randomized dose and were analyzed. The need for ketamine redosing was higher in the 1mg/kg group (8/50; 16.0% vs 1/35; 2.9% vs 2/40; 5.0%). There was no significant difference in the median Ramsay sedation scores (5.5 [interquartile range {IQR}, 4-6] vs 6 [IQR, 4-6] vs 6 [IQR, 5-6]), FACES-R score (0 [IQR, 0-4] vs 0 [IQR, 0-0] vs 0 [IQR, 0-0]), sedation duration in minutes (23 [IQR, 19-38] vs 24.5 [IQR, 17.5-34.5] vs 23 [IQR, 19-29]), and adverse events (10.0% vs 14.3% vs 10.0%) between the 3 dosing groups. Physician satisfaction was lower in the 1mg/kg group (79.6% vs 94.1% vs 97.3%). CONCLUSIONS: Adequate sedation was achieved with all 3 doses of ketamine. Higher doses did not increase the risk of adverse events or prolong sedation. Ketamine administered at 1.5 or 2.0mg/kg intravenous required less redosing and resulted in greater physician satisfaction.

A Misdirected Patient Transfer Raises Emergency Medical Treatment and Labor Act Liability Issues.

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.

Update on pharmacological management of procedural sedation for children.

PURPOSE OF REVIEW: The review provides an update on pharmacological techniques for procedural sedation for children outside the operating room. RECENT FINDINGS: An increasing number of studies of propofol, ketamine, nitrous oxide, dexmedetomidine, and intranasal administration of drugs for procedural sedation of children continue to be reported. SUMMARY: Propofol and ketamine are commonly used for procedural sedation in children and the use of dexmedetomidine and nitrous oxide is increasing. Although the intravenous route remains the mainstay; intranasal drug administration is increasingly used for anxiolysis and moderate sedation.

An update on pediatric hospital-based sedation.

PURPOSE OF REVIEW: The need for sedation for procedures performed outside the operating room has increased dramatically, and pediatric procedural sedation (PPS) is increasingly performed by practitioners who are not anesthesiologists. With 'sedationists' emerging from various specialties, there are differences in practice and guidelines with regards to presedation assessment, targeted depths of sedation, monitoring requirements, and the training required. Our aim is to identify some of the recent advances in PPS and to describe progress towards greater standardization of practice. RECENT FINDINGS: Several studies report attempts to optimize the efficacy of specific pharmaceuticals used in PPS. Ketamine, a dissociative agent, functions uniquely and requires its own sedation practice guidelines. Utilizing less invasive administration of sedation via transmucosal and inhaled routes is gaining popularity. Additionally, replacing subjective measurement of depths of the sedation continuum and the nonstandardized definitions of adverse events with alternatives based on physiological parameters and/or required rescue interventions is underway. Finally, the use of presedation family-centered counseling and adjuncts that provide visual and auditory distraction are enhancing pharmaceutical methods. SUMMARY: Further multispecialty collaboration and formation of greater consensus with regards to sedation practice are essential to the development of universal guidelines that optimize patient care.

Etomidate for short pediatric procedures in the emergency department.

OBJECTIVE: This study aimed to prospectively determine the etomidate dose associated with adequate sedation and few significant respiratory events for procedures of short duration in children. METHODS: This is a prospective cohort study in an urban pediatric emergency department of patients 4 to 18 years requiring sedation and analgesia for painful procedures of short duration. Patients received fentanyl 1 µg/kg followed by intravenously administered etomidate 0.1 to 0.2 mg/kg as a loading dose. An additional dose of etomidate 0.1 mg/kg was intravenously administered if needed. The level of sedation was determined by The Children's Hospital of Wisconsin Sedation Score. The primary outcome was to determine the etomidate dose associated with an adequate level of sedation and procedural completion. RESULTS: Sixty patients were enrolled. The most frequent procedure was fracture reduction (50/60, 83.3%). Procedures were successfully completed for 59 (98.3%) of 60 patients. The initial dose of etomidate associated with adequate sedation was 0.2 mg/kg intravenously administered for 33 (66.7%) of 50 patients requiring fracture reduction and for 6 (60.0%) of 10 patients receiving a procedure other than fracture reduction. Respiratory depression was noted in 9 (16.4%) of 55 patients, and oxygen desaturation was noted in 23 (39.0%) of 59 patients. Of 58 patients, 21 (36.2%) experienced a respiratory adverse event requiring brief intervention including oxygen supplementation, stimulation, and/or airway repositioning. No patient experienced a significant adverse respiratory event, defined as positive pressure ventilation. Median time to discharge-ready was 21 minutes. CONCLUSIONS: For short-duration painful emergency department procedures, etomidate 0.2 mg/kg intravenously administered after fentanyl was associated with effective sedation, successful procedural completion, and readily managed respiratory adverse events in children.

Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update.

We update an evidence-based clinical practice guideline for the administration of the dissociative agent ketamine for emergency department procedural sedation and analgesia. Substantial new research warrants revision of the widely disseminated 2004 guideline, particularly with respect to contraindications, age recommendations, potential neurotoxicity, and the role of coadministered anticholinergics and benzodiazepines. We critically discuss indications, contraindications, personnel requirements, monitoring, dosing, coadministered medications, recovery issues, and future research questions for ketamine dissociative sedation.