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Procedural sedation for direct current cardioversion: a feasibility study between two management strategies in the emergency department.

ABSTRACT: BACKGROUND:A cardiologist-only approach to procedural sedation with midazolam in the setting of elective cardioversion (DCC) for AF has already been proven as safe as sedation with propofol and anaesthesiologist assistance. No data exist regarding the safety of such a strategy during emergency procedures. The aim of this study is to compare the feasibility of sedation with midazolam, administered by a cardiologist, to an anaesthesiologist-assisted protocol with propofol in emergency DCC. METHODS:Single centre, prospective, open blinded, randomized study including all consecutive patients admitted to the Emergency Department requiring urgent or emergency DCC. Patients were randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the midazolam group were managed by the cardiologist only, while patients treated with propofol group underwent DCC with anaesthesiologist assistance. RESULTS:Sixty-nine patients were enrolled and split into two groups. Eighteen patients (26.1%) experienced peri-procedural adverse events (bradycardia, severe hypotension and severe hypoxia), which were similar between the two groups and all successfully managed by the cardiologist. No deaths, stroke or need for invasive ventilation were registered. Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam. As the procedure was shorter when midazolam was used, the median cost of urgent/emergency DCC with midazolam was estimated to be 129.0 € (1st-3rd quartiles 114.6-151.6) and 195.6 € (1st-3rd quartiles 147.3-726.7) with propofol (p?

SUBMITTER: Stronati G

PROVIDER: S-EPMC7449000 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Procedural sedation for direct current cardioversion: a feasibility study between two management strategies in the emergency department.

Stronati Giulia G Capucci Alessandro A Dello Russo Antonio A Adrario Erica E Carsetti Andrea A Casella Michela M Donati Abele A Guerra Federico F

BMC cardiovascular disorders 20200825 1

<h4>Background</h4>A cardiologist-only approach to procedural sedation with midazolam in the setting of elective cardioversion (DCC) for AF has already been proven as safe as sedation with propofol and anaesthesiologist assistance. No data exist regarding the safety of such a strategy during emergency procedures. The aim of this study is to compare the feasibility of sedation with midazolam, administered by a cardiologist, to an anaesthesiologist-assisted protocol with propofol in emergency DCC. ...[more]

PMID: 32842955

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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: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.

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.

Project description:ObjectivesThis was a systematic review and meta-analysis to evaluate the incidence of adverse events in adults undergoing procedural sedation in the emergency department (ED).MethodsEight electronic databases were searched, including MEDLINE, EMBASE, EBSCO, CINAHL, CENTRAL, Cochrane Database of Systematic Reviews, Web of Science, and Scopus, from January 2005 through 2015. Randomized controlled trials and observational studies of adults undergoing procedural sedation in the ED that reported a priori selected outcomes and adverse events were included. Meta-analysis was performed using a random-effects model and reported as incidence rates with 95% confidence intervals (CIs).ResultsThe search yielded 2,046 titles for review. Fifty-five articles were eligible, including 9,652 procedural sedations. The most common adverse event was hypoxia, with an incidence of 40.2 per 1,000 sedations (95% CI = 32.5 to 47.9), followed by vomiting with 16.4 per 1,000 sedations (95% CI = 9.7 to 23.0) and hypotension with 15.2 per 1,000 sedations (95% CI = 10.7 to 19.7). Severe adverse events requiring emergent medical intervention were rare, with one case of aspiration in 2,370 sedations (1.2 per 1,000), one case of laryngospasm in 883 sedations (4.2 per 1,000), and two intubations in 3,636 sedations (1.6 per 1,000). The incidence of agitation and vomiting were higher with ketamine (164.1 per 1,000 and 170.0 per 1,000, respectively). Apnea was more frequent with midazolam (51.4 per 1,000), and hypoxia was less frequent in patients who received ketamine/propofol compared to other combinations. The case of laryngospasm was in a patient who received ketamine, and the aspiration and intubations were in patients who received propofol. When propofol and ketamine are combined, the incidences of agitation, apnea, hypoxia, bradycardia, hypotension, and vomiting were lower compared to each medication separately.ConclusionsSerious adverse events during procedural sedation like laryngospasm, aspiration, and intubation are exceedingly rare. Quantitative risk estimates are provided to facilitate shared decision-making, risk communication, and informed consent.

Project description:ObjectivesDeep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient-centered clinical outcomes were assessed to better plan for a future large-scale clinical trial.DesignPragmatic, multicenter ( n = 3), prospective before-after pilot and feasibility trial.SettingThe ED and ICUs at three medical centers.PatientsConsecutive, adult mechanically ventilation ED patients.InterventionsAn educational initiative aimed at reliable ED sedation depth documentation and reducing the proportion of deeply sedated patients (primary outcome).Measurements and main resultsSedation-related data in the ED and the first 48 ICU hours were recorded. Deep sedation was defined as a Richmond Agitation-Sedation Scale of -3 to -5 or a Sedation-Agitation Scale of 1-3. One thousand three hundred fifty-six patients were screened; 415 comprised the final population. Lighter ED sedation was achieved in the intervention group, and the proportion of deeply sedated patients was reduced from 60.2% to 38.8% ( p < 0.01). There were no concerning trends in adverse events (i.e., inadvertent extubation, device removal, and awareness with paralysis). Mortality was 10.0% in the intervention group and 20.4% in the preintervention group ( p < 0.01). Compared with preintervention, the intervention group experienced more ventilator-free days [22.0 (9.0) vs 19.9 (10.6)] and ICU-free days [20.8 (8.7) vs 18.1 (10.4)], p < 0.05 for both.ConclusionsThis pilot trial confirmed the feasibility of targeting the ED in order to improve sedation practices and reduce deep sedation. These findings justify an appropriately powered clinical trial regarding ED-based sedation to improve clinical outcomes.

Dataset Information

Procedural sedation for direct current cardioversion: a feasibility study between two management strategies in the emergency department.

Publications

Procedural sedation for direct current cardioversion: a feasibility study between two management strategies in the emergency department.

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