Intranasal fentanyl and discharge from the emergency department among children with sickle cell disease and vaso-occlusive pain: A multicenter pediatric emergency medicine perspective.

Children with sickle cell disease (SCD) commonly experience vaso-occlusive pain episodes (VOE) due to sickling of erythrocytes, which often requires care in the emergency department. Our objective was to assess the use and impact of intranasal fentanyl for the treatment of children with SCD-VOE on discharge from the emergency department in a multicenter study. We conducted a cross-sectional study at 20 academic pediatric emergency departments in the United States and Canada. We used logistic regression to test bivariable and multivariable associations between the outcome of discharge from the emergency department and candidate variables theoretically associated with discharge. The study included 400 patients; 215 (54%) were female. The median age was 14.6 (interquartile range 9.8, 17.6) years. Nineteen percent (n = 75) received intranasal fentanyl in the emergency department. Children who received intranasal fentanyl had nearly nine-fold greater adjusted odds of discharge from the emergency department compared to those who did not (adjusted odds ratio 8.99, 95% CI 2.81-30.56, p < .001). The rapid onset of action and ease of delivery without intravenous access offered by intranasal fentanyl make it a feasible initial parenteral analgesic in the treatment of children with SCD presenting with VOE in the acute-care setting. Further study is needed to determine potential causality of the association between intranasal fentanyl and discharge from the emergency department observed in this multicenter study.

Emergency Laboratory Evaluations for Patients With Inborn Errors of Metabolism.

BACKGROUND: Children with inborn errors of metabolism (IEM) are at risk for metabolic crises triggered by acute illnesses. Crises are identified through laboratory evaluations. OBJECTIVES: Our objective was to determine national adherence to minimum laboratory evaluations for patients with IEM in emergency departments (EDs), as well as factors associated with laboratory evaluation adherence. METHODS: Using the Pediatric Health Information System, we identified visits to 48 EDs from 2012 to 2017 by children with IEM. We analyzed visits for catabolic conditions (dehydration, gastroenteritis, or vomiting) and determined variation in minimum laboratory evaluation adherence. Multivariable models were created to determine predictors of adherence. RESULTS: Among the visits by children with disorders of the urea cycle, organic acid metabolism, and fatty acid oxidation, 1457 (76.3%) of 1909 adhered to the minimum laboratory evaluation. Median ED-level adherence was 78.2% (interquartile range, 67.4-92.5). Factors associated with adherence were disorder [fatty acid oxidation vs urea cycle disorder; adjusted odds ratio (aOR), 9.35; 95% confidence interval (CI), 4.07-21.47], annual ED volume of patients with IEM (quartile 4 vs 1; aOR, 3.58; 95% CI, 1.51-8.49), and presence of a biochemical genetics fellowship (aOR, 0.29; 95% CI, 0.14-0.62). CONCLUSIONS: Patients with IEM frequently did not receive minimum laboratory evaluations for catabolic conditions. Measures to improve laboratory use in children with IEM should be undertaken.

Normal saline bolus use in pediatric emergency departments is associated with poorer pain control in children with sickle cell anemia and vaso-occlusive pain.

Vaso-occlusive pain events (VOE) are the leading cause of emergency department (ED) visits in sickle cell anemia (SCA). This study assessed the variability in use of intravenous fluids (IVFs), and the association of normal saline bolus (NSB), on pain and other clinical outcomes in children with SCA, presenting to pediatric emergency departments (PED) with VOE. Four-hundred charts of children age 3-21 years with SCA/VOE receiving parenteral opioids at 20 high-volume PEDs were evaluated in a retrospective study. Data on type and amount of IVFs used were collected. Patients were divided into two groups: those who received NSB and those who did not. The association of NSB use on change in pain scores and admission rates was evaluated. Among 400 children studied, 261 (65%) received a NSB. Mean age was 13.8 ± 4.9 years; 46% were male; 92% had hemoglobin-SS. The IVFs (bolus and/or maintenance) were used in 84% of patients. Eight different types of IVFs were utilized and IVF volume administered varied widely. Mean triage pain scores were similar between groups, but improvement in pain scores from presentation-to-ED-disposition was smaller in the NSB group (2.2 vs 3.0, P = .03), while admission rates were higher (71% vs 59%, P = .01). Use of NSB remained associated with poorer final pain scores and worse change in pain scores in our multivariable model. In conclusion, wide variations in practice utilizing IVFs are common. NSB is given to >50% of children with SCA/VOE, but is associated with poorer pain control; a controlled prospective trial is needed to determine causality.

Rapid cycle deliberate practice vs. traditional simulation in a resource-limited setting.

BACKGROUND: We sought to develop a low-fidelity simulation-based curriculum for pediatric residents in Rwanda utilizing either rapid cycle deliberate practice (RCDP) or traditional debriefing, and to determine whether RCDP leads to greater improvement in simulation-based performance and in resident confidence compared with traditional debriefing. METHODS: Pediatric residents at the Centre Hospitalier Universitaire de Kigali (CHUK) were randomly assigned to RCDP or traditional simulation and completed a 6 month-long simulation-based curriculum designed to improve pediatric resuscitation skills. Pre- and post- performance was assessed using a modified version of the Simulation Team Assessment Tool (STAT). Each video-taped simulation was reviewed by two investigators and inter-rater reliability was assessed. Self-confidence in resuscitation, pre- and post-simulation, was assessed by Likert scale survey. Analyses were conducted using parametric and non-parametric testing, ANCOVA and intra-class correlation coefficients (ICC). RESULTS: There was a 21% increase in pre- to post-test performance in both groups (p < 0.001), but no difference between groups (mean difference - 0.003%; p 0.94). Inter-rater reliability was exceptional with both pre and post ICCs ≥0.95 (p < 0.001). Overall, self-confidence scores improved from pre to post (24.0 vs. 30.0 respectively, p < 0.001), however, the there was no difference between the RCDP and traditional groups. CONCLUSIONS: Completion of a six-month low-fidelity simulation-based curriculum for pediatric residents in Rwanda led to statistically significant improvement in performance on a simulated resuscitation. RCDP and traditional low-fidelity simulation-based instruction may both be valuable tools to improve resuscitation skills in pediatric residents in resource-limited settings.

Health care system hazard vulnerability analysis: an assessment of all public hospitals in Abu Dhabi.

Hazard vulnerability analysis (HVA) is used to risk-stratify potential threats, measure the probability of those threats, and guide disaster preparedness. The primary objective of this project was to analyse the level of disaster preparedness in public hospitals in the Emirate of Abu Dhabi, utilising the HVA tool in collaboration with the Disaster Medicine Section at Harvard Medical School. The secondary objective was to review each facility's disaster plan and make recommendations based on the HVA findings. Based on the review, this article makes eight observations, including on the need for more accurate data; better hazard assessment capabilities; enhanced decontamination capacities; and the development of hospital-specific emergency management programmes, a hospital incident command system, and a centralised, dedicated regional disaster coordination centre. With this project, HVAs were conducted successfully for the first time in health care facilities in Abu Dhabi. This study thus serves as another successful example of multidisciplinary emergency preparedness processes.

Pediatric disaster preparedness curriculum across emergency medicine residencies.

OBJECTIVE: To assess pediatric disaster medicine (PDM) instruction in emergency medicine (EM) residency programs and to identify barriers to integrating these skills into EM training. METHODS: National survey study of United States EM Residency Program Directors (PDs) and Assistant PDs during the 2021-2022 academic year. RESULTS: Of the 186 EM residency programs identified, a total of 24 responses were recorded with a response rate of 12.9 percent. Importance of training was rated 5.79 (standard deviation 2.51) using the Likert scale ranging from 1 to 10. Out of 24 programs, 17 (70.8 percent) do not have any PDM training as part of residency training. Live drill, simulation, and tabletop were identified as most effective methods to deliver PDM training with the Likert scale score of 4.78, 4.6, and 4.47, respectively. Senior trainees' level of -knowledge/skills with family reunification (Likert 2.09/5; chemical-biological-radiological-nuclear explosive 2.95/5) and mass casualty preparation of the emergency department (3.3/5) as assessed by the respondents. The main barrier to education included logistics, eg, space and costs (Likert 3.7/5), lack of didactic time (3.7/5), and limited faculty knowledge, skill, or experience (3.3/5). CONCLUSION: PDM training is lacking and requires standardization. This study highlights the opportunity for the creation of a model for EM resident education in PDM.

Development and evaluation of a novel knowledge assessment tool for pediatric emergency medicine clerkships.

Objectives: This study seeks to determine validity evidence for a newly developed multiple-choice examination (MCE) tool to assess retention and application of medical knowledge of students enrolled in a pediatric emergency medicine (PEM) clerkship. Methods: A team of PEM physicians created a 110-item MCE covering the range of clinical topics in PEM relevant for medical students. The researchers determined examination content using the report of Clerkship Directors in Emergency Medicine and PEM Interest Group of the Society for Academic Emergency Medicine (SAEM). The authors administered the MCE to fourth-year medical students at the end of their PEM rotation from May 2020 to April 2023 at four institutions and then analyzed the examination using four of Messick's five sources of validity evidence: content, response process, internal structure, and relation to other variables. Results: A total of 158 students took the test. In academic year (AY)20-21, 47 students took the test and scored, on average, 81%. After revision of poor and indeterminate questions, the 111 medical students who took the revised version of the test in AY21-AY23 scored on average 77.3% with a standard deviation of 5.7% with a normal distribution in scores. The revised questions were rated as excellent (10.0%), good (26.4%), fair (34.5%), poor (24.5%), or indeterminate (4.5%) based on test item discrimination. There was a positive correlation between MCE scores and students' clinical evaluations but no correlation between MCE scores and scores that students received on their clinical notes or patient presentations during case conference. Conclusions: This novel PEM clerkship examination is a reliable test of medical knowledge. Future directions involve evaluating consequences of the MCE and offering the test to medical students in a dedicated PEM rotation at the national level.

Red blood cell alloimmunization in sickle cell disease: prevalence in 2010.

BACKGROUND: Transfusion of red blood cells (RBCs) is frequently required for care of individuals with sickle cell disease (SCD). Alloimmunization rates are high and may be reduced by matching for RBC antigens that can cause alloimmunization. STUDY DESIGN AND METHODS: During the PROACTIVE Feasibility Study, patients with SCD age 2 years or older admitted for pain without acute chest syndrome were enrolled for possible randomization to preventive blood transfusion or standard care. Transfusion and antibody histories were obtained at each site, and antibody screening was done, to assess transfusion burden and alloimmunization prevalence. Participating sites were surveyed regarding antigen matching practice. RESULTS: A total of 237 patients (169 SS, 42 SC, 15 Sß(0) -thalassemia, 11 Sß(+) -thalassemia), 118 males and 119 females, were enrolled. Mean age was 19.3 years (range, 2.0-68.0); there were 122 children and 115 adults. A total of 75.8% had received at least a single transfusion of RBCs before the study. Thirty-four patients (14.4%) had a history of at least one alloantibody and 17 of these had more than one. When surveyed, 19 sites (83% of responders) reported antigen matching to at least include C, E, and K for transfusion of all patients with SCD. CONCLUSION: Though antigen typing before transfusion of people with SCD and providing antigen-negative units is now widely employed by sickle cell centers, the alloimmunization rate remains quite high in contemporary sickle cell populations and may be due in large part to transfusions received at institutions not providing extended matching.

IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies.

BACKGROUND: The hallmark of sickle cell disease (SCD) is pain from a vaso-occlusive crisis. Although ambulatory pain accounts for most days in pain, pain is also the most common cause of hospitalization and is typically treated with parenteral opioids. The evidence base is lacking for most analgesic practice in SCD, particularly for the optimal opioid dosing for patient-controlled analgesia (PCA), in part because of the challenges of the trial design and conduct for this rare disease. PURPOSE: The purpose of this report is to describe our Network's experiences with protocol development, implementation, and analysis, including overall study design, the value of pain assessments rather than 'crisis' resolution as trial endpoints, and alternative statistical analysis strategies. METHODS: The Improving Pain Management and Outcomes with Various Strategies (IMPROVE) PCA trial was a multisite inpatient randomized controlled trial comparing two PCA-dosing strategies in adults and children with SCD and acute pain conducted by the SCD Clinical Research Network. The specified primary endpoint was a 25-mm change in a daily average pain intensity using a Visual Analogue Scale, and a number of related pain intensity and pain interference measures were selected as secondary efficacy outcomes. A time-to-event analysis strategy was planned for the primary endpoint. RESULTS: Of 1116 individuals admitted for pain at 31 participating sites over a 6-month period, 38 were randomized and 4 withdrawn. The trial was closed early due to poor accrual, reflecting a substantial number of challenges encountered during trial implementation. LIMITATIONS: While some of the design issues were unique to SCD or analgesic studies, many of the trial implementation challenges reflected the increasing complexity of conducting clinical trials in the inpatient setting with multiple care providers and evolving electronic medical record systems, particularly in the context of large urban academic medical centers. LESSONS LEARNED: Complicated clinical organization of many sites likely slowed study initiation. More extensive involvement of research staff and site principal investigator in the clinical care operations improved site performance. During the subsequent data analysis, alternative statistical approaches were considered, the results of which should inform future efficacy assessments and increase future trial recruitment success by allowing substantial reductions in target sample size. CONCLUSIONS: A complex randomized analgesic trial was initiated within a multisite disease network seeking to provide an evidence base for clinical care. A number of design considerations were shown to be feasible in this setting, and several pain intensity and pain interference measures were shown to be sensitive to time- and treatment-related improvements. While the premature closure and small sample size precluded definitive conclusions regarding treatment efficacy, this trial furnishes a template for design and implementation considerations that should improve future SCD analgesic trials.

Use of an automated case log to improve trainee evaluations on a pediatric emergency medicine rotation.

OBJECTIVE: Providing meaningful evaluation to trainees rotating through the pediatric emergency medicine is important yet challenging. Information systems can be used to autopopulate an electronic case log, which can be leveraged to assist in the evaluation process. The objective of this study was to determine if a novel educational initiative using an automated case log improved faculty evaluation of trainees. METHODS: This retrospective study examined faculty completion rate, as well as the content of medical student evaluations over a 3-academic-year study period. Three phases of evaluation were utilized: written, electronic, and electronic enhanced with individualized case reports created with the automated case log. The primary outcome was faculty response rate. Secondary outcomes included word count and the number of themes identified following qualitative analysis of narrative responses. Logistic regression was performed. RESULTS: Forty-one faculty members completed evaluations of 43 students. The rates of completion for the written, electronic, and automated case log phases were 18%, 16%, and 62%, respectively. Faculty in the automated case log phase were significantly more likely to complete evaluations compared with those in the written evaluation phase (odds ratio, 7.6; 95% confidence interval, 4.5-13.0). The median word counts across the 3 phases were 19, 36, and 43, respectively. The median numbers of themes identified during the 3 phases were 3, 4, and 5, respectively. The differences in the word count and median number of themes between the written and automated case log phases were significantly different (P < 0.001). CONCLUSIONS: The process of trainee evaluation can be improved by utilizing an automated case log to provide faculty members with individualized reports of shared patient encounters.

Pediatric Casualties in Terrorist Attacks: A Semi-Quantitative Analysis of Global Events.

BACKGROUND: Terrorism remains a major threat and concern in many countries around the world. Pediatric populations represent approximately 30% of the world population, and in the event of a terrorist attack, can either be primary targets, to include the possibility of abduction, or unintended victims. They are unique in their vulnerabilities and, therefore, require special consideration. METHODS: This study is a semi-quantitative, epidemiological analysis of all terrorism-related pediatric fatalities and injuries sustained from 1970-2019. Data collection was performed using a retrospective database search through the Global Terrorism Database (GTD). Summaries of events including search terms associated with pediatric population were individually reviewed and those describing the deaths, injuries, or abductions were tallied. RESULTS: Of the over 200,000 terror events, 2,302 events met inclusion criteria. This represented 1.14% of total events which involved death, injury, or abduction. Of 2,032 events, a total of 2,275 pediatric fatal injuries (FI) were recorded, as well as 2,280 pediatric non-fatal injuries (NFI). The most common weapons used in all attacks involving the pediatric population were explosives (1,539 [66.8%]), firearms (543 [23.5%]), other (169 [7.3%]), and melee (83 [3.6%]). A total of 275 of the 2,032 events were related to abductions, with 71 cases involving the abduction of 10 individuals or more. CONCLUSION: Pediatric casualties in terrorist events represent a small proportion of overall victims. However, it should be understood that the pediatric population has unique vulnerabilities, and when directly impacted by terrorism, can have long-term physical and psychosocial sequelae, as well as a devastating emotional impact on the community.

Opioid patient controlled analgesia use during the initial experience with the IMPROVE PCA trial: a phase III analgesic trial for hospitalized sickle cell patients with painful episodes.

Opioid analgesics administered by patient-controlled analgesia (PCA)are frequently used for pain relief in children and adults with sickle cell disease (SCD) hospitalized for persistent vaso-occlusive pain, but optimum opioid dosing is not known. To better define PCA dosing recommendations,a multi-center phase III clinical trial was conducted comparing two alternative opioid PCA dosing strategies (HDLI­higher demand dose with low constant infusion or LDHI­lower demand dose and higher constant infusion) in 38 subjects who completed randomization prior to trial closure. Total opioid utilization (morphine equivalents,mg/kg) in 22 adults was 11.6 ± 2.6 and 4.7 ± 0.9 in the HDLI andin the LDHI arms, respectively, and in 12 children it was 3.7 ± 1.0 and 5.8 ± 2.2, respectively. Opioid-related symptoms were mild and similar in both PCA arms (mean daily opioid symptom intensity score: HDLI0.9 ± 0.1, LDHI 0.9 ± 0.2). The slow enrollment and early study termination limited conclusions regarding superiority of either treatment regimen. This study adds to our understanding of opioid PCA usage in SCD. Future clinical trial protocol designs for opioid PCA may need to consider potential differences between adults and children in PCA usage.

Clinical practice guideline improves the treatment of sickle cell disease vasoocclusive pain.

BACKGROUND: Pain is the most common complication of sickle cell disease requiring emergency department (ED) visits and hospitalization. A Clinical Practice Guideline (CPG) to manage acute sickle cell pain offers clinicians a standardized approach for the provision of evidence-based, cost-effective care. After CPG implementation, monitoring of pre-established indicators is a strategy to evaluate progress toward meeting the goal of providing rapid, effective pain relief for patients with acute sickle cell pain. METHODS: A retrospective chart review of patients with sickle cell disease admitted through the ED at Children's Hospital Boston with the primary diagnosis of vaso-occlusive pain was performed for a period before and after implementation of the CPG. Endpoints measured were: use of a validated pain scale, time from ED triage to first dose of analgesic, use of adequate weight-based analgesic dosing, frequency and location of PCA initiation, and time from ED triage to patient controlled analgesia (PCA) initiation. RESULTS: Two hundred sixty three sickle cell pain admissions in 93 unique subjects were analyzed, 51 pre-CPG and 212 post-CPG. Statistically significant improvements in use of pain scale, appropriate weight-based analgesic dosing, utilization of PCA, and time to initiation of PCA were observed. There was not a statistically significant improvement in the percentage of subjects who received their 1st dose of analgesic within 1 hr; however the median time to first analgesic was reduced significantly from 80 to 65 min (P = 0.003). CONCLUSIONS: Implementation of a CPG to manage acute sickle cell pain in the ED improves the ability to deliver timely, effective analgesia to this patient population. Establishing and monitoring internal benchmarks provides a means for ongoing evaluation of the pre-established goals for patient care.

Advanced training in pediatric emergency medicine in the United States, Canada, United Kingdom, and Australia: an international comparison and resources guide.

Pediatric emergency medicine is an important subspecialty of pediatrics and emergency medicine. It is a well-established subspecialty in some countries and less well developed or evolving in others. We set out to develop a resource guide and document the current status of pediatric emergency medicine training across 4 countries (United States, Canada, United Kingdom, and Australia). This article also aims to provide a starting point for pediatric or emergency physicians charged with the development of pediatric emergency medicine training programs in countries without such programs.

Monitoring participant safety in phase I and II interventional trials: options and controversies.

BACKGROUND: The need for phase I and II clinical trials to have a data and safety monitoring plan (DSMP) is widely accepted; however, whether and/or when these trials should also have oversight by a data and safety monitoring board (DSMB) is controversial. Monitoring requirements also depend on whether the study is funded by the National Institutes of Health, funded and/or monitored by the US Food and Drug Administration (FDA), or funded by industry. However, there is little guidance about when and how to constitute a DSMB for phase I and II clinical trials. OBJECTIVES: The objectives of this article are to suggest guidelines for when and how to constitute a DSMB for phase I and II studies and to highlight the similarities and differences between DSMBs monitoring phase I and II versus phase III clinical studies. We highlight the utility of these guidelines in the safety monitoring of a mechanism of disease-based study of inhaled nitric oxide for acute vaso-occlusive crisis in pediatric patients with sickle cell disease that was funded and regulated by the FDA. CONCLUSION: The goal of DSMPs regardless of the phase of the clinical trial is to protect participant safety and ensure the integrity and validity of the data. A DSMB can ensure that risks and data are evaluated in a timely, efficient, and unbiased manner. We describe "risk-based" guidelines to determine situations in which a DSMB may be an appropriate addition to a DSMP for phase I and II clinical trials. We also address the roles and responsibilities of the DSMB for these studies.

A simulator-based tool that assesses pediatric resident resuscitation competency.

BACKGROUND: Competency in pediatric resuscitation is an essential goal of pediatric residency training. Both the exigencies of patient care and the Accreditation Council for Graduate Medical Education require assessment of this competency. Although there are standard courses in pediatric resuscitation, no published, validated assessment tool exists for pediatric resuscitation competency. OBJECTIVE: The purpose of this work was to develop a simulation-based tool for the assessment of pediatric residents' resuscitation competency and to evaluate the tool's reliability and preliminarily its validity in a pilot study. METHODS: We developed a 72-question yes-or-no questionnaire, the Tool for Resuscitation Assessment Using Computerized Simulation, representing 4 domains of resuscitation competency: basic resuscitation, airway support, circulation and arrhythmia management, and leadership behavior. We enrolled 25 subjects at each of 5 different training levels who all participated in 3 standardized code scenarios using the Laerdal SimMan universal patient simulator. Performances were videotaped and then reviewed by 2 independent expert raters. RESULTS: The final version of the tool is presented. The intraclass correlation coefficient between the 2 raters ranged from 0.70 to 0.76 for the 4 domain scores and was 0.80 for the overall summary score. Between the 2 raters, the mean percent exact agreement across items in each domain ranged from 81.0% to 85.1% and averaged 82.1% across all of the items in the tool. Across subject groups, there was a trend toward increasing scores with increased training, which was statistically significant for the airway and summary scores. CONCLUSIONS: In this pilot study, the Tool for Resuscitation Assessment Using Computerized Simulation demonstrated good interrater reliability within each domain and for summary scores. Performance analysis shows trends toward improvement with increasing years of training, providing preliminary construct validity.

Computerized recruiting for clinical trials in real time.

STUDY OBJECTIVE: Success of prospective studies, particularly in the emergency department, often depends on immediate identification of eligible patients to ensure timely sample collection and initiation of study interventions. We report use of a real-time automated notification system to identify potential patients for a clinical trial at the time of ED registration on the basis of information routinely collected. We hypothesize that the automated notification system improves the rate of investigator notification. METHODS: We performed a prospective comparison of the notification rate by the automated notification system compared with that by ED clinicians. RESULTS: In the 11 months before use of the automated notification system, the investigator was notified by ED staff for 56% of 61 potentially eligible patients. During 10 months of using the automated notification system, the investigator was paged by the automated notification system for 84% of 49 potentially eligible patients. CONCLUSION: The automated notification system improves study investigator notification. Use requires online linked registration, a database, and paging systems. The automated notification system is a potentially valuable tool in the recruitment of patients for clinical trials.