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.

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.

ED RAPID: A Novel Children's Hospital Direct Admission Process Utilizing the Emergency Department.

INTRODUCTION: Direct hospital admission of children without evaluation in the emergency department (ED) is common, but few guidelines exist to maximize safety by assessing patient stability. This report describes a novel approach to support patient safety. METHODS: An interdisciplinary children's hospital team developed a brief ED-based evaluation process called the ED Rapid Assessment of Patients Intended for Inpatient Disposition (ED RAPID). It entails a brief evaluation of vital signs and clinical stability by the ED attending physician and nurse. Children deemed stable are admitted to inpatient wards, whereas those requiring immediate intervention undergo full ED evaluation and disposition. We assessed outcomes for all children evaluated through this process from March 2013 through February 2015. RESULTS: During the study period, we identified 715 patients undergoing ED RAPID evaluation. Of these, we directly admitted 691 (96.4%) to the hospital ward after ED RAPID evaluation; median ED treatment time was 4.0 minutes. We transitioned 24 (3.4%) to full ED evaluation, 14 (2.0%) because a ward bed was unavailable, and 10 (1.4%) for clinical reasons identified in the evaluation. We admitted four of the 10 stopped (40% of stops, 0.6% of total) to an intensive care unit, and 6 (60% of stops, 0.8% of total) to the hospital ward after ED care. Eight children (1.1%) admitted to the hospital ward after ED RAPID evaluation required a transfer to an intensive care unit within 12 hours. CONCLUSION: The ED RAPID evaluation process for children directly admitted to the hospital was feasible and effective in this setting.

Impact of Timing of Preprocedural Opioids on Adverse Events in Procedural Sedation.

BACKGROUND: The risk of respiratory depression is increased when opioids are added to sedative agents. In our recent multicenter emergency department (ED) procedural sedation cohort, we reported a strong association between preprocedural opioids and sedation-related adverse events. We sought to examine the association between timing of opioids and the incidence of adverse sedation outcomes. METHODS: We conducted a secondary analysis of a prospective cohort of children aged 0 to 18 years who received sedation for a painful procedure in six Canadian pediatric EDs from July 2010 to February 2015. The primary risk factor was timing of opioid administration, adjusted for age, opioid type, preprocedural and sedation medications, and procedure type. Outcomes were 1) oxygen desaturation, 2) vomiting, and 3) positive pressure ventilation (PPV). RESULTS: Of the 6,295 children in the original cohort, 1,806 (29%) received a preprocedural opioid. Patients receiving preprocedural opioids had a higher incidence of oxygen desaturation (risk difference = 4.3%, 95% confidence interval [CI] = 2.9% to 5.8%), vomiting (risk difference 2.0%, 95% CI = 0.7% to 3.3%), and PPV (risk difference = 1.5%, 95% CI = 0.7% to 2.3%). Multivariable regression with timing of opioids modeled as a restricted cubic spline revealed the risk for each outcome was highest when opioids were administered in the 30 minutes prior to sedation. Timing of opioid administration was statistically significantly associated with oxygen desaturation and vomiting (p < 0.0001) but not with PPV (p = 0.113). CONCLUSIONS: Timing of opioids was significantly associated with the risk of oxygen desaturation and vomiting. Being aware of this increased risk will help clinicians prepare for sedation and the potential need for patient rescue.

Results from the Adverse Event Sedation Reporting Tool: A Global Anthology of 7952 Records Derived from >160,000 Procedural Sedation Encounters.

Background: The incidence of sedation-related adverse events, inclusive of both adults and children, administered by multiple specialty providers from different countries and venues, using standardized definitions, has never been reported on an international level. We are reporting the outcome data of the adverse event sedation reporting tool as an important step toward a more complete risk assessment of sedation-related morbidity, mortality, and etiology. The analysis of the AE sedation reporting data include descriptive measures to evaluate the characteristics of the provider, the patient, sedations performed, adverse events, interventions, and outcomes. The primary outcome was the rate and nature of adverse events. Between 12/14/2010 and 12/11/2018 there were 7952 sedations, from an estimated total of 164,114 sedations administered, of which 622 were reported as adverse events. The mean age of the entire patient population is 33.0 years (0.02-98.7). The providers represented 39 countries across six continents. Oxygen desaturation (75%-90%) for <60 s is the most prevalent adverse event with a rate of 7.8 per 10,000, followed by airway obstruction at a rate of 5.42 per 10,000. Apnea occurred at a rate of 4.75 per 10,000. Significant predictors of adverse events are ≥ ASA score III (p = 0.0003), procedure time (6:00 pm-12:00 am: p < 0.0001, 12:00-6:00 am: p = 0.0003), and non-hospital location (p < 0.0001). The AE sedation reporting tool has demonstrated that the majority of adverse events in children and adults who receive procedural sedation from multi-specialists internationally required minor interventions and had outcomes of minor risk.

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.

Hospital Course of Croup After Emergency Department Management.

OBJECTIVES: To describe inpatient management of patients with croup admitted from the emergency department (ED). METHODS: In a multicentered, cross-sectional observational study based on retrospective chart review, we identified children 6 months to 5 years of age with a discharge diagnosis of croup. All patients were evaluated in the ED and treated with at least 1 dose of racemic epinephrine (RE) before admission. Children with hypoxia or directly admitted to the PICU were excluded. RESULTS: We identified 628 admissions for croup. Significant interventions, defined as additional RE, helium-oxygen use, or PICU transfer, occurred in 142 patients (22.6%). A total of 137 children received additional RE on the inpatient ward, and 5 received RE and were transferred to the PICU. No patient was treated with helium-oxygen. A total 486 (77.4%) of patients did not receive significant interventions postadmission. Length of stay for children not requiring significant intervention was, on average, <24 hours (18.8 hours [SD 9.3]; range 1.2-111 hours). Children with tachypnea (odds ratio = 2.5; P = .002) on arrival to ED and patients who had ED radiographs (odds ratio = 1.7; P = .018) had increased odds of receiving a significant intervention after admission. CONCLUSIONS: Less than one-quarter of children admitted to the general wards for croup received significant interventions after admission. Tachypnea in the ED and use of radiograph were associated with an increased use of significant interventions.

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.

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.

Intravenous Ketamine for Adolescents with Treatment-Resistant Depression: An Open-Label Study.

BACKGROUND: Novel interventions for treatment-resistant depression (TRD) in adolescents are urgently needed. Ketamine has been studied in adults with TRD, but little information is available for adolescents. This study investigated efficacy and tolerability of intravenous ketamine in adolescents with TRD, and explored clinical response predictors. METHODS: Adolescents, 12-18 years of age, with TRD (failure to respond to two previous antidepressant trials) were administered six ketamine (0.5 mg/kg) infusions over 2 weeks. Clinical response was defined as a 50% decrease in Children's Depression Rating Scale-Revised (CDRS-R); remission was CDRS-R score ≤28. Tolerability assessment included monitoring vital signs and dissociative symptoms using the Clinician-Administered Dissociative States Scale (CADSS). RESULTS: Thirteen participants (mean age 16.9 years, range 14.5-18.8 years, eight biologically male) completed the protocol. Average decrease in CDRS-R was 42.5% (p = 0.0004). Five (38%) adolescents met criteria for clinical response. Three responders showed sustained remission at 6-week follow-up; relapse occurred within 2 weeks for the other two responders. Ketamine infusions were generally well tolerated; dissociative symptoms and hemodynamic symptoms were transient. Higher dose was a significant predictor of treatment response. CONCLUSIONS: These results demonstrate the potential role for ketamine in treating adolescents with TRD. Limitations include the open-label design and small sample; future research addressing these issues are needed to confirm these results. Additionally, evidence suggested a dose-response relationship; future studies are needed to optimize dose. Finally, questions remain regarding the long-term safety of ketamine as a depression treatment; more information is needed before broader clinical use.

Association of Preprocedural Fasting With Outcomes of Emergency Department Sedation in Children.

Importance: It is not clear whether adherence to preprocedural fasting guidelines prevent pulmonary aspiration and associated adverse outcomes during emergency department (ED) sedation of children. Objective: To examine the association between preprocedural fasting duration and the incidence of sedation-related adverse outcomes in a large sample of children. Design, Setting, and Participants: We conducted a planned secondary analysis of a multicenter prospective cohort study of children aged 0 to 18 years who received procedural sedation for a painful procedure in 6 Canadian pediatric EDs from July 2010 to February 2015. The primary risk factor was preprocedural fasting duration. Secondary risk factors were age, sex, American Society of Anesthesiologists classification, preprocedural and sedation medications, and procedure type. Main Outcomes and Measures: Four outcomes were examined: (1) pulmonary aspiration, (2) the occurrence of any adverse event, (3) serious adverse events, and (4) vomiting. Results: A total of 6183 children with a median age of 8.0 years (interquartile range, 4.0-12.0 years), of whom 6166 (99.7%) had healthy or mild systemic disease (American Society of Anesthesiologists levels I or II), were included in the analysis. Of these, 2974 (48.1%) and 310 (5.0%) children did not meet American Society of Anesthesiologists fasting guidelines for solids and liquids, respectively. There were no cases of pulmonary aspiration. There were 717 adverse events (11.6%; 95% CI, 10.8%-12.4%), of which 68 (1.1%; 95% CI, 0.9%-1.3%) were serious adverse events and 315 (5.1%; 95% CI, 4.6%-5.7%) were vomiting. The odds ratio (OR) of occurrence of any adverse event, serious adverse events, and vomiting did not change significantly with each additional hour of fasting duration for both solids (any adverse event: OR, 1.00; 95% CI, 0.98 to 1.02; serious adverse events, OR, 1.01; 95% CI, 0.95-1.07; vomiting: OR, 1.00; 95% CI, 0.97-1.03) and liquids (any adverse event: OR, 1.00; 95% CI, 0.98-1.02; serious adverse events: 1.01, 95% CI, 0.95-1.07; vomiting: OR, 1.00; 95% CI, 0.96-1.03). Conclusions and Relevance: In this study, there was no association between fasting duration and any type of adverse event. These findings do not support delaying sedation to meet established fasting guidelines.

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.

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.

Risk Factors for Adverse Events in Emergency Department Procedural Sedation for Children.

Importance: Procedural sedation for children undergoing painful procedures is standard practice in emergency departments worldwide. Previous studies of emergency department sedation are limited by their single-center design and are underpowered to identify risk factors for serious adverse events (SAEs), thereby limiting their influence on sedation practice and patient outcomes. Objective: To examine the incidence and risk factors associated with sedation-related SAEs. Design, Setting, and Participants: This prospective, multicenter, observational cohort study was conducted in 6 pediatric emergency departments in Canada between July 10, 2010, and February 28, 2015. Children 18 years or younger who received sedation for a painful emergency department procedure were enrolled in the study. Of the 9657 patients eligible for inclusion, 6760 (70.0%) were enrolled and 6295 (65.1%) were included in the final analysis. Exposures: The primary risk factor was receipt of sedation medication. The secondary risk factors were demographic characteristics, preprocedural medications and fasting status, current or underlying health risks, and procedure type. Main Outcomes and Measures: Four outcomes were examined: SAEs, significant interventions performed in response to an adverse event, oxygen desaturation, and vomiting. Results: Of the 6295 children included in this study, 4190 (66.6%) were male and the mean (SD) age was 8.0 (4.6) years. Adverse events occurred in 736 patients (11.7%; 95% CI, 6.4%-16.9%). Oxygen desaturation (353 patients [5.6%]) and vomiting (328 [5.2%]) were the most common of these adverse events. There were 69 SAEs (1.1%; 95% CI, 0.5%-1.7%), and 86 patients (1.4%; 95% CI, 0.7%-2.1%) had a significant intervention. Use of ketamine hydrochloride alone resulted in the lowest incidence of SAEs (17 [0.4%]) and significant interventions (37 [0.9%]). The incidence of adverse sedation outcomes varied significantly with the type of sedation medication. Compared with ketamine alone, propofol alone (3.7%; odds ratio [OR], 5.6; 95% CI, 2.3-13.1) and the combinations of ketamine and fentanyl citrate (3.2%; OR, 6.5; 95% CI, 2.5-15.2) and ketamine and propofol (2.1%; OR, 4.4; 95% CI, 2.3-8.7) had the highest incidence of SAEs. The combinations of ketamine and fentanyl (4.1%; OR, 4.0; 95% CI, 1.8-8.1) and ketamine and propofol (2.5%; OR, 2.2; 95% CI, 1.2-3.8) had the highest incidence of significant interventions. Conclusions and Relevance: The incidence of adverse sedation outcomes varied significantly with type of sedation medication. Use of ketamine only was associated with the best outcomes, resulting in significantly fewer SAEs and interventions than ketamine combined with propofol or fentanyl.

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.