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.

Tracheal Intubation by Advanced Practice Registered Nurses in Pediatric Critical Care: Retrospective Study From the National Emergency Airway for Children Registry (2015-2019).

Objectives: To describe tracheal intubation (TI) practice by Advanced Practice Registered Nurses (APRNs) in North American PICUs, including rates of TI-associated events (TIAEs) from 2015 to 2019.

Design/setting: Retrospective study using the National Emergency Airway Registry for Children with all TIs performed in PICU and pediatric cardiac ICU between January 2015 and December 2019. The primary outcome was first attempt TI success rate.

Associations With Severe Desaturation Events Among Children Receiving Noninvasive Respiratory Support at Time of Intubation.

Background: Endotracheal intubation is a common procedure associated with adverse events, including severe desaturation. Many patients receive noninvasive respiratory support to reduce the need for intubation. There are minimal data about the association between noninvasive respiratory support and the risk of a severe desaturation event during intubation.

A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age.

Background: Enteral ibuprofen was first approved as a prescription drug in 1974 for the US market. An intravenous (IV) ibuprofen formulation is approved for use in children older than 6 months of age, but there are limited studies specifically evaluating the pharmacokinetics and safety in children 1-6 months of age.

Aims: The primary purpose of this study was to evaluate the pharmacokinetics of IV ibuprofen in infants younger than 6 months of age.

Ketamine Use in the Intubation of Critically Ill Children with Neurological Indications: A Multicenter Retrospective Analysis.

Background: Ketamine has traditionally been avoided for tracheal intubations (TIs) in patients with acute neurological conditions. We evaluate its current usage pattern in these patients and any associated adverse events.

Methods: We conducted a retrospective observational cohort study of critically ill children undergoing TI for neurological indications in 53 international pediatric intensive care units and emergency departments.

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

Rationale: A guideline that both evaluates current practice and provides recommendations to address sedation, pain, and delirium management with regard for neuromuscular blockade and withdrawal is not currently available.

Objective: To develop comprehensive clinical practice guidelines for critically ill infants and children, with specific attention to seven domains of care including pain, sedation/agitation, iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment, and early mobility.

Design: The Society of Critical Care Medicine Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility Guideline Taskforce was comprised of 29 national experts who collaborated from 2009 to 2021 via teleconference and/or e-mail at least monthly for planning, literature review, and guideline development, revision, and approval.

Analysis of Viscoelastic Testing in Pediatric Patients Using the Pediatric Extracorporeal Membrane Oxygenation Outcomes Registry.

Use of viscoelastic tests (VETs), including thromboelastography (TEG) and rotational thromboelastometry (ROTEM), is increasing in the management of anticoagulation in extracorporeal membrane oxygenation (ECMO) patients. A retrospective review of data on 265 pediatric (<20 years old) ECMO patients who underwent VET and were submitted to the Pediatric ECMO Outcomes Registry (PEDECOR) was conducted to describe common coagulopathies in patients who underwent VET; associations between the VET parameters and traditional tests of coagulation; and comparisons in blood product usage in patients who underwent VET with those who did not. We calculated patient-level summary statistics and assessed differences between the groups using χ2 tests (categorical variables) and Kruskal-Wallis and Wilcoxon rank-sum tests (continuous variables).

The New Trainee Effect in Tracheal Intubation Procedural Safety Across PICUs in North America: A Report From National Emergency Airway Registry for Children.

Objectives: Tracheal intubation carries a high risk of adverse events. The current literature is unclear regarding the "New Trainee Effect" on tracheal intubation safety in the PICU. We evaluated the effect of the timing of the PICU fellow academic cycle on tracheal intubation associated events.

Safety of prolonged magnesium sulfate infusions during treatment for severe pediatric status asthmaticus.

Objective: Magnesium sulfate (Mg) is one of several "second-tier" therapies for treating severe status asthmaticus. Pediatric reports primarily describe bolus use with limited data regarding prolonged infusions. We sought to describe the safety of prolonged Mg infusions during therapy of status asthmaticus in critically ill children.

Use of Thromboelastography to Predict Thrombotic Complications in Pediatric and Neonatal Extracorporeal Membranous Oxygenation.

The objectives of this study were to investigate the correlation between thromboelastography (TEG) and conventional measures of anticoagulation, and to determine optimum values for citrated kaolin TEG R time (TEG RCK) and anti-Xa activity that would minimize both bleeding and thrombotic complications in pediatric and neonatal patients requiring extracorporeal membranous oxygenation (ECMO). A retrospective chart review of patients requiring veno-venous (VV) and venoarterial (VA) ECMO was performed. Combined medical and cardiac ICU within a single-center, tertiary care, freestanding, children's hospital.

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.

Procedural sedation in children with autism spectrum disorders: A survey of current practice patterns of the society for pediatric sedation members.

Background: Children with autism spectrum disorder are challenging to sedate because of communication, sensory, and behavioral challenges.

Aims: The aim of this survey was to determine how procedural sedation is provided to children with autism spectrum disorders and whether sedation programs have specialized protocols for procedural sedation of these children.

Methods: We surveyed physician Medical Directors of sedation programs who are members of the Society for Pediatric Sedation, asking about practice characteristics and resource utilization during procedural sedation of children with autism spectrum disorders.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: 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 public-private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, (2) efficacy, (3) patient-centered and/or family-centered outcomes, and (4) efficiency. This meeting identified core outcome measures within the efficacy and patient-centered and/or family-centered domains.

When the Mannequin Dies, Creation and Exploration of a Theoretical Framework Using a Mixed Methods Approach.

Introduction: Controversy exists in the simulation community as to the emotional and educational ramifications of mannequin death due to learner action or inaction. No theoretical framework to guide future investigations of learner actions currently exists. The purpose of our study was to generate a model of the learner experience of mannequin death using a mixed methods approach.

Options and Considerations for Procedural Sedation in Pediatric Imaging.

As pediatric imaging capabilities have increased in scope, so have the complexities of providing procedural sedation in this environment. While efforts by many organizations have dramatically increased the safety of pediatric procedural sedation in general, radiology sedation creates several special challenges for the sedation provider. These challenges require implementation of additional safeguards to promote safety during sedation while maintaining effective and efficient care.

The impact of obesity on pediatric procedural sedation-related outcomes: results from the Pediatric Sedation Research Consortium.

Objectives: To evaluate the impact of obesity on adverse events and required interventions during pediatric procedural sedation.

Methods: The Pediatric Sedation Research Consortium database of prospectively collected procedural sedation encounters was queried to identify patients for whom body mass index (BMI) could be calculated. Obesity was defined as BMI ≥95th percentile for age and gender.

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

Background: No standardized educational curriculum exists for pediatric sedation practitioners. We sought to describe the curriculum and implementation of a pediatric sedation provider course and assess learner satisfaction with the course curriculum.

Description: The course content was determined by formulating a needs assessment using published sedation guidelines, reports of sedation related adverse events, and a survey of sedation practitioners.

Pretreatment with midazolam blunts the rise in intracranial pressure associated with ketamine sedation for lumbar puncture in children.

Objective: Ketamine has a long history of use during pediatric procedural sedation. Concerns about raising intracranial pressure may limit use in certain situations. Whereas some data suggest that benzodiazepine coadministration may blunt this response, pediatric data during procedural sedation do not exist.

Clevidipine for perioperative blood pressure control in infants and children undergoing cardiac surgery for congenital heart disease.

Objective: To determine the efficacy and adverse effect profile of clevidipine when used for perioperative blood pressure (BP) control during surgery for congenital heart disease (CHD).

Methods: We retrospectively reviewed our experience with the perioperative use of clevidipine in pediatric-aged patients undergoing surgery for CHD.

Results: The study cohort included 14 patients ranging from 11 months to 15 years (7.

Atrial fibrillation after taser exposure in a previously healthy adolescent.

We are reporting a previously healthy adolescent who developed atrial fibrillation after being tased. He has a structurally normal heart on echocardiogram, normal electrolyte level and thyroid function test results, and a urine toxicology screen positive for marijuana. The patient ultimately required external defibrillation to convert his cardiac rhythm to normal sinus rhythm and has had no recurrent arrhythmias since hospital discharge (approximately 1 year).