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.

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. Sedation-related outcomes, adverse events, and therapeutic interventions were compared between obese and nonobese patients. RESULTS: For analysis, 28,792 records were eligible. A total of 5,153 patients (17.9%) were obese; they were predominantly male and older and had a higher median American Society of Anesthesiologists Physical Status classification (P < 0.001). Total adverse events were more common in obese patients (odds ratio [OR] 1.49, 95% confidence interval [1.31, 1.70]). Respiratory events (airway obstruction OR 1.94 [1.54, 2.44], oxygen desaturation OR 1.99 [1.50, 2.63], secretions OR 1.48 [1.01, 2.15], laryngospasm OR 2.30 [1.30, 4.05]), inability to complete the associated procedure (OR 1.96 [1.16, 3.30]), and prolonged recovery (OR 2.66 [1.26, 5.59]) were increased in obese patients. Obese patients more frequently required airway intervention including repositioning, suctioning, jaw thrust, airway adjuncts, and bag-valve-mask ventilation. Multivariate regression analysis demonstrated obesity to be independently associated with minor and moderate but not major adverse events. CONCLUSIONS: Obesity is an independent risk factor for adverse respiratory events during procedural sedation and is associated with an increased frequency of airway interventions, suggesting that additional vigilance and expertise are required when sedating these patients.

Great expectations-defining quality in pediatric sedation: outcomes of a multidisciplinary consensus conference.

PURPOSE: Recognizing the inconsistencies in sedation practices, the Society for Pediatric Sedation convened this meeting to begin the process of defining quality as it relates to the field of pediatric sedation. SCOPE: Millions of procedures are performed each year on children. Caring for children, even for routine procedures, can be challenging. Children may not have the ability to follow commands, tolerate painful stimuli, or even lie still for a diagnostic study. Therefore, pharmacologic sedation with medications designed to blunt the awareness of the patient and provide relief of pain and anxiety is necessary. METHODS: A multidisciplinary group of sedation providers and quality methodology experts met in November 2011. Through 2 days of didactics, small workgroups, and consensus discussions, the attendees met the objectives of exploring quality in pediatric sedation around the Institute of Medicine's () six aims of quality: Safe, Effective, Patient Centered, Timely, Efficient, and Equitable. RESULTS: The conference findings outlined in this document address the Agency for Healthcare Research and Quality's (AHRQ) mission of improving quality healthcare for all Americans, especially for underrepresented groups such as children. The conference outlines a key next step in defining and achieving quality in pediatric procedural sedation.

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

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

Safe and sound: pediatric procedural sedation and analgesia.

Providing procedural sedation for pediatric patients presents unique challenges. Children's hospitals have protocols in place to provide safe, high-quality sedation care delivered by specialists in pediatric sedation and anesthesiology. However, the demand for procedural sedation for diagnostic and therapeutic procedures is increasing. This article describes some of the key components involved in establishing a protocol for safe and effective pediatric sedation services including screening techniques for patients at higher risk for complications and appropriate monitoring and rescue plans. We also review medications commonly used for pediatric sedation and pain management and discuss resources available to physicians who provide pediatric sedation.