2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility.

RATIONALE: A guideline that both evaluates current practice and provides recommendations to address sedation, pain, and delirium management with regard for neuromuscular blockade and withdrawal is not currently available. OBJECTIVE: To develop comprehensive clinical practice guidelines for critically ill infants and children, with specific attention to seven domains of care including pain, sedation/agitation, iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment, and early mobility. DESIGN: The Society of Critical Care Medicine Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility Guideline Taskforce was comprised of 29 national experts who collaborated from 2009 to 2021 via teleconference and/or e-mail at least monthly for planning, literature review, and guideline development, revision, and approval. The full taskforce gathered annually in-person during the Society of Critical Care Medicine Congress for progress reports and further strategizing with the final face-to-face meeting occurring in February 2020. Throughout this process, the Society of Critical Care Medicine standard operating procedures Manual for Guidelines development was adhered to. METHODS: Taskforce content experts separated into subgroups addressing pain/analgesia, sedation, tolerance/iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment (family presence and sleep hygiene), and early mobility. Subgroups created descriptive and actionable Population, Intervention, Comparison, and Outcome questions. An experienced medical information specialist developed search strategies to identify relevant literature between January 1990 and January 2020. Subgroups reviewed literature, determined quality of evidence, and formulated recommendations classified as "strong" with "we recommend" or "conditional" with "we suggest." Good practice statements were used when indirect evidence supported benefit with no or minimal risk. Evidence gaps were noted. Initial recommendations were reviewed by each subgroup and revised as deemed necessary prior to being disseminated for voting by the full taskforce. Individuals who had an overt or potential conflict of interest abstained from relevant votes. Expert opinion alone was not used in substitution for a lack of evidence. RESULTS: The Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility taskforce issued 44 recommendations (14 strong and 30 conditional) and five good practice statements. CONCLUSIONS: The current guidelines represent a comprehensive list of practical clinical recommendations for the assessment, prevention, and management of key aspects for the comprehensive critical care of infants and children. Main areas of focus included 1) need for the routine monitoring of pain, agitation, withdrawal, and delirium using validated tools, 2) enhanced use of protocolized sedation and analgesia, and 3) recognition of the importance of nonpharmacologic interventions for enhancing patient comfort and comprehensive care provision.

Outcomes of Children With Critical Bronchiolitis Meeting at Risk for Pediatric Acute Respiratory Distress Syndrome Criteria.

OBJECTIVES: New definitions of pediatric acute respiratory distress syndrome include criteria to identify a subset of children "at risk for pediatric acute respiratory distress syndrome." We hypothesized that, among PICU patients with bronchiolitis not immediately requiring invasive mechanical ventilation, those meeting at risk for pediatric acute respiratory distress syndrome criteria would have worse clinical outcomes, including higher rates of pediatric acute respiratory distress syndrome development. DESIGN: Single-center, retrospective chart review. SETTING: Mixed medical-surgical PICU within a tertiary academic children's hospital. PATIENTS: Children 24 months old or younger admitted to the PICU with a primary diagnosis of bronchiolitis from September 2013 to April 2014. Children intubated before PICU arrival were excluded. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Collected data included demographics, respiratory support, oxygen saturation, and chest radiograph interpretation by staff radiologist. Oxygen flow (calculated as FIO2 × flow rate [L/min]) was calculated when oxygen saturation was 88-97%. The median age of 115 subjects was 5 months (2-11 mo). Median PICU length of stay was 2.8 days (1.5-4.8 d), and median hospital length of stay was 5 days (3-10 d). The criteria for at risk for pediatric acute respiratory distress syndrome was met in 47 of 115 subjects (40.9%). Children who were at risk for pediatric acute respiratory distress syndrome were more likely to develop pediatric acute respiratory distress syndrome (15/47 [31.9%] vs 1/68 [1.5%]; p < 0.001), had longer PICU length of stay (4.6 d [2.8-10.2 d] vs 1.9 d [1.0-3.1 d]; p < 0.001) and hospital length of stay (8 d [5-16 d] vs 4 d [2-6 d]; p < 0.001), and increased need for invasive mechanical ventilation (16/47 [34.0%] vs 2/68 [2.9%]; p < 0.001), compared with those children who did not meet at risk for pediatric acute respiratory distress syndrome criteria. CONCLUSIONS: Our data suggest that the recent definition of at risk for pediatric acute respiratory distress syndrome can successfully identify children with critical bronchiolitis who have relatively unfavorable clinical courses.

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.

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.

Prevalence and Predictors of Adverse Events during Procedural Sedation Anesthesia-Outside the Operating Room for Esophagogastroduodenoscopy and Colonoscopy in Children: Age Is an Independent Predictor of Outcomes.

OBJECTIVES: Procedural sedation/anesthesia outside the operating room for a variety of procedures is well described with an overall low adverse event rate in certain settings. Adverse event associated with procedural sedation/anesthesia outside the operating room for gastrointestinal procedures have been described, albeit in small, single-center studies with wide variance in outcomes. Predictors of such outcomes are unclear. We aimed to estimate the prevalence of adverse event in children undergoing procedural sedation/anesthesia outside the operating room for esophagogastroduodenoscopy, colonoscopy, or both to identify predictors of adverse event. DESIGN/SETTING/PATIENTS: Retrospective analysis of Pediatric Sedation Research Consortium database, a large data repository of pediatric patients aged 21 years old or younger undergoing procedural sedation/anesthesia outside the operating room during September 2007 to November 2011. Twenty-two of the 40 centers provided data pertaining to the procedure of interest. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Primary outcome variable is any adverse event. Independent variables include: age (five groups), sex, American Societyof Anaesthesiologists status, procedure (esophagogastroduodenoscopy, colonoscopy, or both), provider responsible, medication used, location, and presence of coexisting medical conditions. Descriptive statistics used to summarize the data. Using multivariablelogistic regression model, odds ratio, 95% CI) were computed. A total of 12,030 procedures were performed (esophagogastroduodenoscopy, 7,970; colonoscopy, 1,378; and both, 2,682). A total of 96.9% of patients received propofol. Eighty-three percent were performed in a sedation unit. Prevalence of adverse event was 4.8%. The most common adverse event were persistent desaturations (1.5%), airway obstruction (1%), cough (0.9%), and laryngospasm (0.6%). No deaths or CPR occurred. Infants and children aged 5 years old or younger had a higher adverse event rate than older children (15.8%, 7.8% vs 4%). Regression analysis revealed age 5 years old or younger, American Society of Anaesthesiologists greater than or equal to 2, esophagogastroduodenoscopy ± colonoscopy, and coexisting medical conditions of obesity and lower airway disease were independent predictors of higher adverse event. CONCLUSIONS: Overall prevalence of any adverse event was 4.8%. Independent predictors of adverse events in procedural sedation/anesthesia outside the operating room in pediatric esophagogastroduodenoscopy/colonoscopy onoscopy were identified. Recognition of such risk factors may enable optimization of procedural sedation.

Development, implementation, and initial participant feedback of a pediatric sedation provider course.

BACKGROUND: No standardized educational curriculum exists for pediatric sedation practitioners. We sought to describe the curriculum and implementation of a pediatric sedation provider course and assess learner satisfaction with the course curriculum. DESCRIPTION: The course content was determined by formulating a needs assessment using published sedation guidelines, reports of sedation related adverse events, and a survey of sedation practitioners. Students provided feedback regarding satisfaction with the course immediately following the course and 6 months later. EVALUATION: The course consisted of 5 didactic lectures, 1 small-group session, 6 simulation scenarios, a course syllabus, and a written examination. The course was conducted over 1 day at 3 different locations. Sixty-nine students completed the course and were uniformly satisfied with the course curriculum. CONCLUSIONS: A standardized pediatric sedation provider course was developed for sedation practitioners and consisted of a series of lectures and simulation scenarios. Overall satisfaction with the course was positive.

Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

BACKGROUND: Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting. METHODS: The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects. RESULTS: Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation. CONCLUSION: Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved. CLINICALTRIALS: gov #: NCT03938857.

Acute Neuro-Functional Morbidity Upon Discharge From the Pediatric Intensive Care Unit After Critical Bronchiolitis.

BACKGROUND AND OBJECTIVE: Improved survival has shifted research focus toward understanding alternate PICU outcomes, including neurocognitive and functional changes. Bronchiolitis is a common PICU diagnosis, but its neuro-functional outcomes have not been adequately described in contemporary literature. The objective of the study is to describe the epidemiology and associated clinical characteristics of acute neuro-functional morbidity (ANFM) in critical bronchiolitis. METHODS: Patients <2 years old admitted with bronchiolitis between 2014 and 2016 were identified. Demographics, medical history, length of stay (LOS), and need for intubation were collected. Children with a history of neurologic illness or illness associated with neurologic sequelae were termed "high risk"; others were termed "low risk." ANFM was defined both at PICU and hospital discharge as the presence of swallowing difficulty, nasogastric tube feeds, hypotonia, or lethargy. Variables were compared by using χ2 and Wilcoxon rank tests. RESULTS: Among 417 children, 16.7% had ANFM, predominantly swallow difficulties (95.7%). Children with ANFM had lower weight (5.9 [4.4-8.2] vs 7.7 [5.5-9.7] kg, P = .001), longer LOS (6.6 [2.5-13.3] vs 1.9 [0.9-3.5] days, P < .001), intubation (51.4% vs 6.1%, P < .001) and high-risk status (37.1% vs 8.4%, P < .001). Among 362 low risk subjects, ANFM was identified in 44 (12%). In a multivariate logistic regression model, high-risk status, intubation, and ICU LOS were associated with ANFM. ANFM persisted to hospital discharge in 46% of cases. CONCLUSIONS: One out of 6 patients with critical bronchiolitis had documentation consistent with ANFM at PICU discharge. Risk factors included previous neurologic conditions, longer LOS, and intubation. Many were low-risk and/or did not require intubation, indicating a risk for neuro-functional morbidities despite moderate acuity.

A review of key strategies to address the shortage of analgesics and sedatives in pediatric intensive care.

Importance: Targeted analgosedation is a challenge in critically ill children, and this challenge becomes even more significant with drug shortages. Observations: Published guidelines inform the provision of analgosedation in critically ill children. This review provides insights into general approaches using these guidelines during drug shortages in Pediatric Intensive Care Units as well as strategies to optimize both pharmacological and non-pharmacological approaches in these situations. Conclusions and relevance: Considering that drug shortages are a recurrent worldwide problem, this review may guide managing these drugs in critically ill children in situations of scarcity, such as in pandemics or disasters.

Development, Implementation, and Evaluation of a Faculty Development Workshop to Enhance Debriefing Skills Among Novice Facilitators.

Introduction Effective debriefing during simulation-based training (SBT) is critical to promote learning outcomes. Despite debriefing's central role in learning and various published debriefing methods and techniques, little is known about faculty development structure for debriefing training among novice facilitators. Continuing medical education courses often use simulation-based methods but provide minimal training in debriefing techniques to novice facilitators. We describe the development, implementation, and evaluation of a structured debriefing training workshop for novice facilitators. Methods Designed and conducted by simulation debriefing experts, a debriefing workshop was provided to novice facilitators serving as faculty during the simulation-based Sedation Provider Course (PC) at the 2018 Society of Pediatric Sedation conference. Emphasizing evidence-based key elements of effective debriefing, the workshop was divided into three components: 1) an introductory 30 minute didactic, 2) 75 minutes role modeling of simulated effective and ineffective debriefing 3) 120 minutes repetitive deliberate practice sessions with summative and formative feedback. Effective transfer of learned debriefing skills was assessed during facilitators' PC debriefing using the Objective Structured Assessment of Debriefing (OSAD) tool, facilitators' self-efficacy, and PC student learners' evaluation of facilitator debriefings during the PC. Results Sixteen facilitators participated in the 4-h workshop and the next day served as PC faculty. The median OSAD score was 31 (13-40) for all facilitators. OSAD components with lowest and highest performance were "Establishing Learning Environment" with a median score of 1 (1-5) and "Engagement of Learners," with a median score of 4.75 (2.5-5). Facilitators' self- assessment in debriefing significantly improved on the 5-point Likert scale pre- and post-workshop, respectively. PC student learners' evaluations revealed high degrees of satisfaction with debriefing quality. Conclusions A proposed model integrating full-length debriefing and repetitive practice paired with summative and formative feedback provides a feasible and effective approach for debriefing training of novice facilitators for simulation-based educational courses.

Trends in Outpatient Procedural Sedation: 2007-2018.

BACKGROUND: Pediatric subspecialists routinely provide procedural sedation outside the operating room. No large study has reported trends in outpatient pediatric procedural sedation. Our purpose in this study was to identify significant trends in outpatient procedural sedation using the Pediatric Sedation Research Consortium. METHODS: Prospectively collected data from 2007 to 2018 were used for trending procedural sedation. Patient characteristics, medications, type of providers, serious adverse events, and interventions were reported. The Cochran-Armitage test for trend was used to explore the association between the year and a given characteristic. RESULTS: A total of 432 842 sedation encounters were identified and divided into 3 4-year epochs (2007-2011, 2011-2014, and 2014-2018). There was a significant decrease in infants <3 months of age receiving procedural sedation (odds ratio = 0.97; 95% confidence interval, 0.96-0.98). A large increase was noticed in pediatric hospitalists providing procedural sedation (0.6%-9.5%; P < .001); there was a decreasing trend in sedation by other providers who were not in emergency medicine, critical care, or anesthesiology (13.9%-3.9%; P < .001). There was an increasing trend in the use of dexmedetomidine (6.3%-9.3%; P < .001) and a decreasing trend in the use of chloral hydrate (6.3%-0.01%; P < .001) and pentobarbital (7.3%-0.5%; P < .001). Serious adverse events showed a nonsignificant increase overall (1.35%-1.75%). CONCLUSIONS: We report an increase in pediatric hospitalists providing sedation and a significant decrease in the use of chloral hydrate and pentobarbital by providers. Further studies are required to see if sedation services decrease costs and optimize resource use.

Outcomes of Children With Critical Bronchiolitis Living in Poor Communities.

There are established associations between adverse health outcomes and poverty, but little is known regarding these associations in critically ill children. We hypothesized that living in poorer communities would be associated with unfavorable outcomes in children with critical bronchiolitis. This retrospective study included children with bronchiolitis admitted to a pediatric intensive care unit (PICU) over a 2-year period. Median household income was estimated from patient ZIP codes and 2014 US Census Bureau data. The 2014 Federal Poverty Threshold (FPT) for a family of 4 was $24 008. Patients were classified as living in ZIP codes below or above the 150% FPT (150FPT). Living <150FPT was associated with longer PICU length of stay (LOS), longer hospital LOS, higher odds of needing mechanical ventilation, and increased hospital charges. In this cohort of critically ill children with bronchiolitis, living in a poorer community was associated with more unfavorable clinical outcomes.

Nutrition and High-Flow Nasal Cannula Respiratory Support in Children With Bronchiolitis.

OBJECTIVES: No guidelines are available regarding initiation of enteral nutrition in children with bronchiolitis on high-flow nasal cannula (HFNC) support. We hypothesized that the incidence of feeding-related adverse events (AEs) would not be associated with HFNC support. METHODS: This retrospective study included children ≤24 months old with bronchiolitis receiving HFNC in a PICU from September 2013 through April 2014. Data included demographics, respiratory support during feeding, and feeding-related AEs. Feeding-related AEs were extracted from nursing documentation and defined as respiratory distress or emesis. Feed route and maximum HFNC delivery were recorded in 8-hour shifts (6 am-2 pm, 2 pm-10 pm, and 10 pm-6 am). RESULTS: 70 children were included, with a median age of 5 (interquartile range [IQR] 2-10) months. HFNC delivery at feed initiation varied widely, and AEs related to feeding occurred rarely. Children were fed in 501 of 794 (63%) of nursing shifts, with AEs documented in only 29 of 501 (5.8%) of those shifts. The incidence of AEs at varying levels of respiratory support did not differ (P = .092). Children in the "early feeding" (fed within first 2 shifts) group (n = 22) had a shorter PICU length of stay (2.2 days [IQR 1.4-3.9] vs 3.2 [IQR 2.5-5.3], P = .006) and shorter duration of HFNC use (26.0 hours [IQR 15.8-57.0] vs 53.5 [IQR 37.0-84.8], P = .002), compared with children in the "late feeding" group (n = 48). CONCLUSIONS: In this small, single-institution patient cohort, feeding-related AEs were rare and not related to the delivered level of respiratory support.

A thyroglossal duct cyst causing apnea and cyanosis in a neonate.

This is a case of a 3-week-old male who presented to the emergency department with intermittent apnea and cyanosis. While in the emergency department, he had respiratory compromise with stress and required intubation. Further evaluation confirmed the diagnosis of a thyroglossal duct cyst. Congenital lesions causing extrinsic airway compression should be considered in all neonates with apnea, cyanosis, and respiratory compromise. Knowledge of pediatric airway anatomy and physiology is important in all cases where obstructive apnea is suspected.