Dataset Information

Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report From the Pediatric Sedation Research Consortium.

ABSTRACT: 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.

SUBMITTER: Grunwell JR

PROVIDER: S-EPMC6287759 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report From the Pediatric Sedation Research Consortium.

Grunwell Jocelyn R JR Travers Curtis C Stormorken Anne G AG Scherrer Patricia D PD Chumpitazi Corrie E CE Stockwell Jana A JA Roback Mark G MG Cravero Joseph J Kamat Pradip P PP

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies 20170801 8

<h4>Objectives</h4>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.<h4>Design</h4>Prospective observational study of children receiving IV ketamine + propofol for procedural sedation outside of the ...[more]

PMID: 28650904

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Project description:Procedural sedation and analgesia outside the operating theater have become standard care in managing pain and anxiety in children undergoing diagnostic and therapeutic procedures. The objectives of this study are to describe the current pediatric procedural sedation and analgesia practice patterns in European emergency departments, to perform a needs assessment-like analysis, and to identify barriers to implementation. A survey study of European emergency departments treating children was conducted. Through a lead research coordinator identified through the Research in European Pediatric Emergency Medicine (REPEM) network for each of the participating countries, a 30-question questionnaire was sent, targeting senior physicians at each site. Descriptive statistics were performed. One hundred and seventy-one sites participated, treating approximately 5 million children/year and representing 19 countries, with a response rate of 89%. Of the procedural sedation and analgesia medications, midazolam (100%) and ketamine (91%) were available to most children, whereas propofol (67%), nitrous oxide (56%), intranasal fentanyl (47%), and chloral hydrate (42%) were less frequent. Children were sedated by general pediatricians in 82% of cases. Safety and monitoring guidelines were common (74%), but pre-procedural checklists (51%) and capnography (46%) less available. In 37% of the sites, the entire staff performing procedural sedation and analgesia were certified in pediatric advanced life support. Pediatric emergency medicine was a board-certified specialty in 3/19 countries. Physician (73%) and nursing (72%) shortages and lack of physical space (69%) were commonly reported as barriers to procedural sedation and analgesia. Nurse-directed triage protocols were in place in 52% of the sites, mostly for paracetamol (99%) and ibuprofen (91%). Tissue adhesive for laceration repair was available to 91% of children, while topical anesthetics for intravenous catheterization was available to 55%. Access to child life specialists (13%) and hypnosis (12%) was rare.Conclusion: Procedural sedation and analgesia are prevalent in European emergency departments, but some sedation agents and topical anesthetics are not widely available. Guidelines are common but further safety nets, nurse-directed triage analgesia, and nonpharmacologic support to procedural sedation and analgesia are lacking. Barriers to implementation include availability of sedation agents, staff shortage, and lack of space. What is Known: • Effective and prompt analgesia, anxiolysis, and sedation (PSA) outside the operating theatre have become standard in managing pain and anxiety in children undergoing painful or anxiogenic diagnostic and therapeutic procedures. • We searched PubMed up to September 15, 2020, without any date limits or language restrictions, using different combinations of the MeSH terms "pediatrics," "hypnotics and sedatives," "conscious sedation," and "ambulatory surgical procedures" and the non-MeSH term "procedural sedation" and found no reports describing the current practice of pediatric PSA in Europe. What is New: • This study is, to the best of our knowledge, the first to shed light on the pediatric PSA practice in European EDs and uncovers important gaps in several domains, notably availability of sedation medications and topical anesthetics, safety aspects such as PSA provider training, availability of nonpharmacologic support to PSA, and high impact interventions such as nurse-directed triage analgesia. • Other identified barriers to PSA implementation include staff shortage, control of sedation medications by specialists outside the emergency department, and lack of space.

Project description:ImportanceProcedural 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.ObjectiveTo examine the incidence and risk factors associated with sedation-related SAEs.Design, setting, and participantsThis 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.ExposuresThe 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 measuresFour outcomes were examined: SAEs, significant interventions performed in response to an adverse event, oxygen desaturation, and vomiting.ResultsOf 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 relevanceThe 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.

Project description:BackgroundSedation is increasingly used to facilitate procedures on children in emergency departments (EDs). This overview of systematic reviews (SRs) examines the safety and efficacy of sedative agents commonly used for procedural sedation in children in the ED or similar settings.MethodsWe followed standard SR methods: comprehensive search; dual study selection, quality assessment, data extraction. We included SRs of children (1 month to 18 years) where the indication for sedation was procedure-related and performed in the ED.ResultsFourteen SRs were included (210 primary studies). The most data were available for propofol (six reviews/50,472 sedations) followed by ketamine (7/8,238), nitrous oxide (5/8,220), and midazolam (4/4,978). Inconsistent conclusions for propofol were reported across six reviews. Half concluded that propofol was sufficiently safe; three reviews noted a higher occurrence of adverse events, particularly respiratory depression (upper estimate 1.1%; 5.4% for hypotension requiring intervention). Efficacy of propofol was considered in four reviews and found adequate in three. Five reviews found ketamine to be efficacious and seven reviews showed it to be safe. All five reviews of nitrous oxide concluded it is safe (0.1% incidence of respiratory events); most found it effective in cooperative children. Four reviews of midazolam made varying recommendations. To be effective, midazolam should be combined with another agent that increases the risk of adverse events (upper estimate 9.1% for desaturation, 0.1% for hypotension requiring intervention).ConclusionsThis comprehensive examination of an extensive body of literature shows consistent safety and efficacy for nitrous oxide and ketamine, with very rare significant adverse events for propofol. There was considerable heterogeneity in outcomes and reporting across studies and previous reviews. Standardized outcome sets and reporting should be encouraged to facilitate evidence-based recommendations for care.

Project description:OBJECTIVE AND DESIGN:We conducted a systematic review and meta-analysis to evaluate the incidence of adverse events in the emergency department (ED) during procedural sedation in the paediatric population. Randomised controlled trials and observational studies from the past 10?years were included. We adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. SETTING:ED. PARTICIPANTS:Children. INTERVENTIONS:Procedural sedation. OUTCOMES:Adverse events like vomiting, agitation, hypoxia and apnoea. Meta-analysis was performed with random-effects model and reported as incidence rates with 95% CIs. RESULTS:A total of 1177 studies were retrieved for screening and 258 were selected for full-text review. 41 studies reporting on 13?883 procedural sedations in 13?876 children (?18?years) were included. The most common adverse events (all reported per 1000 sedations) were: vomiting 55.5 (CI 45.2 to 65.8), agitation 17.9 (CI 12.2 to 23.7), hypoxia 14.8 (CI 10.2 to 19.3) and apnoea 7.1 (CI 3.2 to 11.0). The need to intervene with either bag valve mask, oral airway or positive pressure ventilation occurred in 5.0 per 1000 sedations (CI 2.3 to 7.6). The incidences of severe respiratory events were: 34 cases of laryngospasm among 8687 sedations (2.9 per 1000 sedations, CI 1.1 to 4.7; absolute rate 3.9 per 1000 sedations), 4 intubations among 9136 sedations and 0 cases of aspiration among 3326 sedations. 33 of the 34 cases of laryngospasm occurred in patients who received ketamine. CONCLUSIONS:Serious adverse respiratory events are very rare in paediatric procedural sedation in the ED. Emesis and agitation are the most frequent adverse events. Hypoxia, a late indicator of respiratory depression, occurs in 1.5% of sedations. Laryngospasm, though rare, happens most frequently with ketamine. The results of this study provide quantitative risk estimates to facilitate shared decision-making, risk communication, informed consent and resource allocation in children undergoing procedural sedation in the ED.

Dataset Information

Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report From the Pediatric Sedation Research Consortium.

Publications

Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report From the Pediatric Sedation Research Consortium.

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