Sedation Research in Critically Ill Pediatric Patients: Proposals for Future Study Design From the Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research IV Workshop.

OBJECTIVES: Sedation and analgesia for infants and children requiring mechanical ventilation in the PICU is uniquely challenging due to the wide spectrum of ages, developmental stages, and pathophysiological processes encountered. Studies evaluating the safety and efficacy of sedative and analgesic management in pediatric patients have used heterogeneous methodologies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) IV hosted a series of multidisciplinary meetings to establish consensus statements for future clinical study design and implementation as a guide for investigators studying PICU sedation and analgesia. DESIGN: Twenty-five key elements framed as consensus statements were developed in five domains: study design, enrollment, protocol, outcomes and measurement instruments, and future directions. SETTING: A virtual meeting was held on March 2-3, 2022, followed by an in-person meeting in Washington, DC, on June 15-16, 2022. Subsequent iterative online meetings were held to achieve consensus. SUBJECTS: Fifty-one multidisciplinary, international participants from academia, industry, the U.S. Food and Drug Administration, and family members of PICU patients attended the virtual and in-person meetings. Participants were invited based on their background and experience. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Common themes throughout the SCEPTER IV consensus statements included using coordinated multidisciplinary and interprofessional teams to ensure culturally appropriate study design and diverse patient enrollment, obtaining input from PICU survivors and their families, engaging community members, and using developmentally appropriate and validated instruments for assessments of sedation, pain, iatrogenic withdrawal, and ICU delirium. CONCLUSIONS: These SCEPTER IV consensus statements are comprehensive and may assist investigators in the design, enrollment, implementation, and dissemination of studies involving sedation and analgesia of PICU patients requiring mechanical ventilation. Implementation may strengthen the rigor and reproducibility of research studies on PICU sedation and analgesia and facilitate the synthesis of evidence across studies to improve the safety and quality of care for PICU patients.

Perinatal Anesthesia Exposure and Autism Spectrum Disorders.

Epidural analgesia is frequently used during labor among pregnant people in the United States. Different factors have been associated with the development of autism spectrum disorder in the epidemiological literature: maternal health, infectious and pharmacological etiologies, social factors, and environmental exposures. Current data indicates no clear association between the use of epidural labor analgesia and the development of autism spectrum disorder in the offspring. This review presents the public health perspective on the postulated association between perinatal anesthesia exposure and autism spectrum disorders.

Impact of Anesthetic Exposures on the Neurocognitive Profiles of Pediatric Brain Tumor Survivors: A New Direction for Research and Multidisciplinary Collaboration.

Primary brain tumors are the most commonly diagnosed solid tumors in children, and pediatric brain tumor survivors experience lasting, pervasive deficits of neurocognitive functioning. Repeated exposure to anesthetic drugs is a necessary component not only of surgical resection but also of multimodal cancer care for the youngest patients with brain tumors. The potential for anesthetic neurotoxicity to worsen neurocognitive outcomes in this vulnerable group, therefore, warrants our attention and further study through multi-disciplinary collaboration. This review discusses neurocognitive functioning in pediatric brain tumor survivors, highlighting the findings of a recent study of children with tumors of the posterior fossa which identified treatment-related risk factors for neurocognitive difficulties, with those undergoing multimodal therapies (eg, chemotherapy and irradiation) experiencing the greatest deficits compared with healthy controls. The role of anesthetic neurotoxicity in long-term outcomes among pediatric brain tumor survivors is also reviewed.

Pediatric Intensive Care Unit Patients: Sedation, Monitoring, and Neurodevelopmental Outcomes.

The design and conduct of pediatric sedation studies in critically ill patients have historically been challenging due to the complexity of the pediatric intensive care unit (PICU) environment and the difficulty of establishing equipoise. Clinical trials, for instance, represent 1 important means of advancing our knowledge in this field, but there is a paucity of such studies in the literature. Accounting for ground-level factors in planning for each trial phase (eg, enrollment, intervention, assessment, and follow-up) and the presence of broader system limitations is of key importance. In addition, there is a need for early planning, coordination, and obtaining buy-in from individual study sites and staff to ensure success, particularly for multicenter studies. This review synthesizes the current state of pediatric sedation research and the myriad of challenges in designing and conducting successful trials in this particular area. The review poses consideration for future research directions, including novel study designs, and discusses electroencephalography monitoring and neurodevelopmental outcomes of PICU survivors.

Variability in Resource Utilization in the Evaluation and Management of Simple Febrile Seizures Inpatients in US Children's Hospitals.

OBJECTIVE: To characterize resource utilization in the evaluation and treatment of hospitalized simple febrile seizure (SFS) patients in US tertiary pediatric hospitals. METHODS: This is a retrospective cohort study using the Pediatric Health Information System from 2010 to 2015. Children 6 months to 5 years of age who were inpatients with a diagnosis of SFS. Children who had brain magnetic resonance imaging (MRI), electroencephalography (EEG), or received anticonvulsants were compared with those who did not have testing or anticonvulsant treatment. Hospital-level variation in the utilization rates of MRI, EEG, or treatment with anticonvulsants was also evaluated. RESULTS: In Pediatric Health Information System-participating institutions, 8.4% (n=3640) of children presenting to the emergency department with SFS were hospitalized. Among these SFS inpatients, 57.8% (n= 2104) did not receive further evaluation with MRI/EEG or treatment with anticonvulsants. There was evidence of wide inter-hospital variation in resource utilization rates. The median (interquartile range) utilization rate was 6.2% (3.0 to 11.0%) for MRI, 28.5% (16.0 to 46.3%) for EEG and 17.1% (10.9 to 22.3%) for treatment with anticonvulsants. CONCLUSION: No specific hospital-level factors were identified that contributed to the variation in resource utilization in the evaluation and management of hospitalized SFS patients.

Adverse Events in the Pediatric Cardiac Catheterization Suite: Does Having Pediatric Cardiac Anesthesiologists Make a Difference?

INTRODUCTION: It has been suggested that anesthesiologists with subspecialty expertise in pediatric cardiac anesthesia are best qualified to care for patients with complex congenital cardiac anomalies and manage the complex physiology frequently encountered in the pediatric cardiac catheterization lab. We evaluated the incidence of adverse events in our pediatric cardiac catheterization lab, comparing care provided by cardiac and noncardiac pediatric attending anesthesiologists. METHODS: Data were collected on each anesthetic in the pediatric cardiac catheterization lab from January 1, 2016 to December 31, 2019. A generalized linear mixed effect model was used to identify associations between pediatric cardiac and noncardiac anesthesiologists and the presence of adverse events adjusting for age, American Society of Anesthesiologists physical status, emergency status, and interventional versus diagnostic procedures. RESULTS: A total of 3,761 procedures involving 1,729 patients were included in the study. There was no significant difference between noncardiac and cardiac anesthesia attendings for overall adverse events (odds ratio [OR], 1.2; 95% confidence interval [CI], 0.82 to 1.75 P=0.349). Specific respiratory adverse events (OR, 1.22; 95%, CI 0.73 to 2.03 P=0.443) or cardiac adverse events (OR, 1.26; 95% CI, 0.64 to 2.48 P=0.502) were also not significantly different with respect to noncardiac compared with cardiac attending anesthesiologists. CONCLUSIONS: In our analysis, the incidence of adverse events in the pediatric cardiac catheterization lab during the study period was not statistically different, whether anesthesia care was provided by a cardiac or a noncardiac anesthesiologist.

Accuracy of diagnostic codes for prenatal opioid exposure and neonatal opioid withdrawal syndrome.

OBJECTIVE: Determine the accuracy of diagnostic codes in identifying Prenatal Opioid Exposure (POE) and Neonatal Opioid Withdrawal Syndrome (NOWS). STUDY DESIGN: A cross-sectional study of 374,222 mother-infant dyads with delivery from 01/01/2010 to 12/31/2019. We ascertained maternal diagnostic codes for opioid use during pregnancy and infant diagnostic codes for drug exposure and withdrawal. We assessed sensitivity and positive predictive value (PPV) for POE and NOWS, defined using laboratory, pharmacy, and clinical data. RESULTS: Maternal codes had low sensitivity (36.4%) and PPV (34.7%) for POE. Infant codes for drug exposure were neither sensitive for POE (14%) nor NOWS (31.6%) and had low PPV. Codes for newborn withdrawal had low sensitivity (31.6%) for detecting NOWS, but high PPV (85%). Sensitivity improved (95.1%) for NOWS requiring pharmacologic treatment. CONCLUSIONS: Diagnostic codes identify POE and NOWS poorly. Improved case identification would include pharmacy and laboratory results, and clearly defined criteria for evidence of withdrawal.

Children with Congenital Heart Disease Show Increased Behavioral Problems Compared to Healthy Peers: A Systematic Review and Meta-Analysis.

Millions of children and adults are living with congenital heart disease (CHD). Their risk for behavioral problems has not been the subject of a meta-analysis. We performed a systematic review and meta-analysis of measures of behavioral problems in people born with CHD compared to peers without CHD. We searched Pubmed, CINAHL, Embase, PsycInfo, and the Cochrane Library from January 1, 1986 to November 15, 2021. We included studies that reported a measure of behavioral problems in patients with CHD in children and adults older than 3 years of age. We screened 26,343 search results, and 24 studies met inclusion criteria. The quality of evidence was generally low. Subjects with CHD had a small increase in internalizing problems [standardized mean difference (SMD): 0.198, p = 0.02] and total behavior problems (SMD: 0.287, p = 0.013), but no difference in externalizing behavioral problems. There was significant heterogeneity in all three domains of behavior problems analyzed, and it could not be explained by variables such as age, severity, assessor, or assessment tool. There are small increases in parent- and self-reported overall behavioral problems and internalizing problems in patients with CHD compared to healthy controls. Wide confidence intervals in the meta-analyses leave open the possibility that certain factors may increase the risk of behavioral problems in this group, and future studies with important attention paid to potential confounders may help identify risk factors.

Anesthesia and Developing Brains: Unanswered Questions and Proposed Paths Forward.

Anesthetic agents disrupt neurodevelopment in animal models, but evidence in humans is mixed. The morphologic and behavioral changes observed across many species predicted that deficits should be seen in humans, but identifying a phenotype of injury in children has been challenging. It is increasingly clear that in children, a brief or single early anesthetic exposure is not associated with deficits in a range of neurodevelopmental outcomes including broad measures of intelligence. Deficits in other domains including behavior, however, are more consistently reported in humans and also reflect findings from nonhuman primates. The possibility that behavioral deficits are a phenotype, as well as the entire concept of anesthetic neurotoxicity in children, remains a source of intense debate. The purpose of this report is to describe consensus and disagreement among experts, summarize preclinical and clinical evidence, suggest pathways for future clinical research, and compare studies of anesthetic agents to other suspected neurotoxins.

Prevalence of SARS-CoV-2 Positivity in Pediatric Surgical Patients Amid the First Wave of the COVID-19 Pandemic in New York City.

INTRODUCTION: New York State implemented an 11-week elective surgery ban in response to the coronavirus disease-2019 (COVID-19) pandemic, during which pediatric patients from the 10 New York Presbyterian network hospitals requiring urgent or emergent surgical procedures were cared for at Morgan Stanley Children's Hospital (MSCH). MATERIALS AND METHODS: Data was abstracted from the electronic medical record of all patients aged 0 to 20 years who had surgery at MSCH from March 23, 2020 to June 7, 2020. Comparative analysis of demographic and clinical data elements between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive and negative cohorts was conducted using the Fisher exact tests. RESULTS: A total of 505 surgical procedures were performed in 451 patients, with 32 procedures (6.3%) performed in 21 SARS-CoV-2-positive children. The prevalence of SARS-CoV-2 positivity in Medicaid beneficiaries was more than twice the prevalence in commercially insured (6.8% vs. 2.6%, P=0.04) children. SARS-CoV-2-positive patients were more likely to undergo multiple surgical procedures (23.8% vs. 7.2%, P=0.02), and to have higher American Society of Anesthesiologists (ASA) class designations (69.8% III to V vs. 47.4% I to II, P=0.03). There was no significant difference in the prevalence of SARS-CoV-2 positivity across sex, age, race, or ethnicity groups, or in emergent case status or surgical procedure type. Thirty-day mortality rate was <0.1% overall, with no deaths in the SARS-CoV-2-positive group. CONCLUSIONS: During the first wave of the COVID-19 pandemic in New York City, we found a higher prevalence of SARS-CoV-2 positivity in urgent/emergent pediatric surgical patients compared with other institutions in the United States. SARS-CoV-2-positive patients were more likely to be Medicaid beneficiaries, were clinically more complex, and had more surgical procedures.

COVID-19 in Pediatric Patients: A Systematic Review.

INTRODUCTION: The coronavirus disease (COVID)-19 pandemic has been an enormous global health burden, resulting in hundreds of millions of documented infections and more than 3 million deaths. Increasing reports characterizing the effects of COVID-19 in pediatric populations have been published during the course of the pandemic. We performed a systematic review to assess the scope of diagnosis, treatment, and management of COVID-19 in pediatric patients. MATERIALS AND METHODS: We searched the Cochrane Database of Systematic Reviews, PubMed, CINAHL, and Embase for studies published between January 1, 2020, and May 1, 2021. Each result was screened by 2 authors independently, and discordant findings were adjudicated by a third party. Data extracted included demographic data, symptom data, and clinical data including mortality, severe illness, laboratory data, radiologic data, and treatment. Bias assessment was performed using the Newcastle-Ottawa Quality Assessment Scale for Cohort Studies. RESULTS: We found a total of 16,266 search results, and we accepted 63 manuscripts into the review. The quality of evidence was low. It was difficult to estimate the risk of mortality in pediatric patients with COVID-19 given the quality of the evidence, but overall it is likely below 1%. The most common symptoms in symptomatic pediatric COVID-19 patients were fever (58%) and cough (50%). There was a high proportion of asymptomatic infection (65%). DISCUSSION: Pediatric COVID-19 infection is mild and frequently asymptomatic. There is a low risk of severe illness or death in children who contract COVID-19. High-quality studies should be conducted to develop best practices for prevention, diagnosis, and management of symptomatic illness.

Development of a preoperative risk score predicting allogeneic red blood cell transfusion in children undergoing spinal fusion.

BACKGROUND: Children undergoing spinal fusion often receive blood products. The goal of this study was to develop a preoperative score to help physicians identify those who are at risk of allogeneic red blood cell (RBC) transfusion. STUDY DESIGN AND METHODS: This retrospective study of children undergoing spinal fusion in the ACS-NSQIP Pediatric database (2016-2019) aimed at identifying risk factors associated with allogeneic RBC transfusion. Univariable logistic regression and multivariable logistic regression were performed using preoperative patient characteristics and aided in the creation of a simplified scoring system. RESULTS: Out of 13,929 total patients, 2990 (21.5%) were transfused. We created a risk score based on 10 independent predictors of transfusion: age, sex, race, weight < 3rd percentile, American Society of Anesthesiologists physical status classification, cardiac risk factors, hematologic disease, preoperative anemia, deformity type, and number of spinal levels to be fused. Patients in both the training and testing cohorts were assigned a score ranging from 0 (lowest risk) to 21 (highest risk). The developed transfusion risk score showed 77% accuracy in distinguishing patients who did not receive a transfusion during or soon after surgery (AUROC 0.7736 [95% CI, 0.7619-0.7852]) in the training cohort and 77% accuracy (AUROC 0.7732 [95% CI, 0.7554-0.7910]) in the testing cohort. DISCUSSION: Our score, based on routinely available preoperative data, accurately estimates the risk of allogeneic RBC transfusion in pediatric patients undergoing spinal fusion. Future studies will inform whether patient blood management interventions targeted to high-risk patients can help reduce the need for transfusion and improve outcomes.

Design and reporting characteristics of clinical trials investigating sedation practices in the paediatric intensive care unit: a scoping review by SCEPTER (Sedation Consortium on Endpoints and Procedures for Treatment, Education and Research).

OBJECTIVES: To conduct a scoping review of sedation clinical trials in the paediatric intensive care setting and summarise key methodological elements. DESIGN: Scoping review. DATA SOURCES: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature and grey references including ClinicalTrials.gov from database inception to 3 August 2021. STUDY SELECTION: All human trials in the English language related to sedation in paediatric critically ill patients were included. After title and abstract screening, full-text review was performed. 29 trials were eligible for final analysis. DATA EXTRACTION: A coding manual was developed and pretested. Trial characteristics were double extracted. RESULTS: The majority of trials were single centre (22/29, 75.9%), parallel group superiority (17/29, 58.6%), double-blinded (18/29, 62.1%) and conducted in an academic setting (29/29, 100.0%). Trial enrolment (≥90% planned sample size) was achieved in 65.5% of trials (19/29), and retention (≥90% enrolled subjects) in 72.4% of trials (21/29). Protocol violations were reported in nine trials (31.0%). The most commonly studied cohorts were mechanically ventilated patients (28/29, 96.6%) and postsurgical patients (11/29, 37.9%) with inclusion criteria for age ranging from 0±0.5 to 15.0±7.3 years (median±IQR). The median age of enrolled patients was 1.7 years (IQR=4.4 years). Patients excluded from trials were those with neurological impairment (21/29, 72.4%), complex disease (20/29, 69.0%) or receipt of neuromuscular blockade (10/29, 34.5%). Trials evaluated drugs/protocols for sedation management (20/29, 69.0%), weaning (3/29, 10.3%), daily interruption (3/29, 10.3%) or protocolisation (3/29, 10.3%). Primary outcome measures were heterogeneous, as were assessment instruments and follow-up durations. CONCLUSIONS: There is substantial heterogeneity in methodological approach in clinical trials evaluating sedation in critically ill paediatric patients. These results provide a basis for the design of future clinical trials to improve the quality of trial data and aid in the development of sedation-related clinical guidelines.

Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation: Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III.

OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators. DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process. PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process. MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization. CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.

Ultrasound Evaluation of Gastric Emptying Time in Healthy Term Neonates after Formula Feeding.

BACKGROUND: The current American Society of Anesthesiologists fasting guideline for formula-fed infants in the periprocedural setting is 6 h. Prolonged fasting in very young infants is associated with an increased risk for hypoglycemia and dehydration as well as patient discomfort and patient/parental dissatisfaction. This study aimed to determine the time to gastric emptying in healthy neonates after formula feeding by serially evaluating the gastric antrum with ultrasound. The authors hypothesized that gastric emptying times in formula-fed neonates are significantly shorter than the current 6 h fasting recommendation. METHODS: After institutional review board approval and written informed parental consent, ultrasound examination was performed in healthy full-term neonates before and after formula feeding at 15-min intervals until return to baseline. Ultrasound images of the gastric antrum were measured to obtain cross-sectional areas, which were then used to estimate gastric antral volumes. RESULTS: Forty-six of 48 recruited neonates were included in the final analysis. Gastric emptying times ranged from 45 to 150 min and averaged 92.9 min (95% CI, 80.2 to 105.7 min; 99% CI, 76.0 to 109.8 min) in the overall study group. No significant differences were found in times to gastric emptying between male and female neonates (male: mean, 93.3 [95% CI, 82.4 to 104.2 min]; female: mean, 92.6 [95% CI, 82.0 to 103.2 min]; P = 0.930) or those delivered by vaginal versus cesarean routes (vaginal: mean, 93.9 [95% CI, 81.7 to 106.1 min]; cesarean: mean, 92.2 [95% CI, 82.5 to 101.9 min]; P = 0.819). CONCLUSIONS: These results demonstrate that gastric emptying times are substantially less than the current fasting guideline of 6 h for formula-fed, healthy term neonates.

Executive functions in children with heart disease: a systematic review and meta-analysis.

CONTEXT: People with CHD are at increased risk for executive functioning deficits. Meta-analyses of these measures in CHD patients compared to healthy controls have not been reported. OBJECTIVE: To examine differences in executive functions in individuals with CHD compared to healthy controls. DATA SOURCES: We performed a systematic review of publications from 1 January, 1986 to 15 June, 2020 indexed in PubMed, CINAHL, EMBASE, PsycInfo, Web of Science, and the Cochrane Library. STUDY SELECTION: Inclusion criteria were (1) studies containing at least one executive function measure; (2) participants were over the age of three. DATA EXTRACTION: Data extraction and quality assessment were performed independently by two authors. We used a shifting unit-of-analysis approach and pooled data using a random effects model. RESULTS: The search yielded 61,217 results. Twenty-eight studies met criteria. A total of 7789 people with CHD were compared with 8187 healthy controls. We found the following standardised mean differences: -0.628 (-0.726, -0.531) for cognitive flexibility and set shifting, -0.469 (-0.606, -0.333) for inhibition, -0.369 (-0.466, -0.273) for working memory, -0.334 (-0.546, -0.121) for planning/problem solving, -0.361 (-0.576, -0.147) for summary measures, and -0.444 (-0.614, -0.274) for reporter-based measures (p < 0.001). LIMITATIONS: Our analysis consisted of cross-sectional and observational studies. We could not quantify the effect of collinearity. CONCLUSIONS: Individuals with CHD appear to have at least moderate deficits in executive functions. Given the growing population of people with CHD, more attention should be devoted to identifying executive dysfunction in this vulnerable group.

Prospectively assessed neurodevelopmental outcomes in studies of anaesthetic neurotoxicity in children: a systematic review and meta-analysis.

BACKGROUND: Whether exposure to a single general anaesthetic (GA) in early childhood causes long-term neurodevelopmental problems remains unclear. METHODS: PubMed/MEDLINE, Embase, CINAHL, Web of Science, and the Cochrane Library were searched from inception to October 2019. Studies evaluating neurodevelopmental outcomes and prospectively enrolling children exposed to a single GA procedure compared with unexposed children were identified. Outcomes common to at least three studies were evaluated using random-effects meta-analyses. RESULTS: Full-scale intelligence quotient (FSIQ); the parentally reported Child Behavior Checklist (CBCL) total, externalising, and internalising problems scores; and Behavior Rating Inventory of Executive Function (BRIEF) scores were assessed. Of 1644 children identified, 841 who had a single exposure to GA were evaluated. The CBCL problem scores were significantly higher (i.e. worse) in exposed children: mean score difference (CBCL total: 2.3 [95% confidence interval {CI}: 1.0-3.7], P=0.001; CBCL externalising: 1.9 [95% CI: 0.7-3.1], P=0.003; and CBCL internalising problems: 2.2 [95% CI: 0.9-3.5], P=0.001). Differences in BRIEF were not significant after multiple comparison adjustment. Full-scale intelligence quotient was not affected by GA exposure. Secondary analyses evaluating the risk of these scores exceeding predetermined clinical thresholds found that GA exposure was associated with increased risk of CBCL internalising behavioural deficit (risk ratio [RR]: 1.47; 95% CI: 1.08-2.02; P=0.016) and impaired BRIEF executive function (RR: 1.68; 95% CI: 1.23-2.30; P=0.001). CONCLUSIONS: Combining results of studies utilising prospectively collected outcomes showed that a single GA exposure was associated with statistically significant increases in parent reports of behavioural problems with no difference in general intelligence.

Outcomes from wake up safe, the pediatric anesthesia quality improvement initiative.

BACKGROUND: Wake Up Safe, a Patient Safety Organization founded by the Society for Pediatric Anesthesia, collects data on serious adverse events along with demographic data from all pediatric patients receiving anesthesia care at participating institutions. This report reviews all events occurring between 2010 and 2015 and focuses on common adverse events that are anesthesia-related. AIMS: Determine which adverse events were most common from 2010 to 2015 among participating Wake Up Safe institutions. Determine how many anesthesia-related events were deemed to be preventable. METHODS: This is a descriptive report. The Wake Up Safe registry data were queried on September 29, 2017. Institutions were included if they had complete demographic data and at least 5 adverse events per year reported. At that time, 19 out of 29 institutions had complete demographic data for events from 2010 to 2015. This study describes demographic data and adverse events from these nineteen institutions. Descriptive data were extracted, and event rate was calculated for each adverse event category. In events that were assessed as primarily related to anesthesia, further detailed analysis was performed. RESULTS: Of all reported adverse events (2544 events), the most common were cardiac arrests (646, 31.6%), respiratory complications (598, 29.2%), and medication events (345, 16.9%). Of all anesthesia-related events (612 events), medication events were the most common (239, 31.9%), followed by respiratory complications (181, 24.1%), and cardiac arrests (139, 18.5%). Overall, 85% of anesthesia-related serious adverse events were deemed somewhat or almost certainly preventable. CONCLUSIONS: The majority of anesthesia-related serious adverse events reported to the Wake Up Safe database are preventable. Medication events are the most common anesthesia-related adverse events. Innovations aimed at decreasing medication events may be the most impactful.