Hrev_master Abstract Procedural Sedation and Analgesia (PSA) is a routine practice in Emergency Departments (EDs) but few data exist in the setting of Italian ED. Thus, this study aimed to describe for the first time an Italian experience of PSA in the ED, defining usual indications, types of drug used, efficacy, and safety. We retrospectively collect- ed consecutive adult patients undergoing PSA in the ED of the Santa Croce e Carle Hospital in Cuneo, Italy, over 6 years; we enrolled all patients who received at least one of the four drugs used for PSA (midazolam, propofol, ketamine, and fentanyl). 384 patients (62.2% male; median age 61 [42;76] years) were included in the study. Two hundred and six PSA (53.7%) were done for orthopedic maneuvers, 103 (26%) for electrical cardioversions (ECV), and 75 (19.5%) for other unpleasant medical procedures. A single drug was used in 132 cases (34.3%), while in 252 (65.7%) an association of at least two drugs was used; 239 patients (62.2%) were ASA class I, 144 (37.5%) were ASA class II and one patient was ASA class III. Three patients (0.8%) experienced PSA failure. Minor adverse events occurred during 16 procedures (4%), while no major adverse events, rescue intubation, or need for escalation of care were registered. PSA is currently used in Italian EDs and it is safe when performed by EPs for patients in ASA class I and II. An Italian prospective PSA register is to be created. Introduction Pain prevalence in the Emergency Departments (EDs) world- wide is high and painful procedures are commonly performed in the EDs.1,2 Procedural sedation and analgesia (PSA) is a critically important component of comprehensive emergency care and it is an essential technique for Emergency Physicians (EPs). The administration of sedatives or dissociative agents, with or without analgesics, induces an altered state of consciousness while preserv- ing cardiorespiratory function, oxygenation, and airway control. This relieves patients’ anxiety, helps them tolerate unpleasant pro- cedures, and facilitates cooperation during potentially painful pro- cedures.3,4 PSA decreases the length of time necessary to perform a procedure, increases the likelihood of success, and reduces the risk of injury to the patient or health care worker due to uncon- trolled movements.5 Multiple studies have shown that PSA is safe when it is done in concordance with current guidelines and that it can be safely and effectively performed by non-anaesthesiologist physicians, both in the care of adult and pediatric emergency populations.4-10 Despite increasing use in recent years, few complete published data exist about the national experience with PSA performed by EPs. This study described for the first time the local experience of an Italian Emergency Care Journal 2024; volume 20:12339 [Emergency Care Journal 2024; 20:12339] [page 99] Procedural sedation and analgesia by Italian emergency physicians: a retrospective observational pilot study Bartolomeo Lorenzati,1,2 Sara Abram,1 Jacopo Davide Giamello,1,3 Alice Bruno,1 Luigi Gambardella,1 Davide Lison,4 Salvatore D’Agnano,1 Gianpiero Martini,1 Andrea Sciolla,1 Giuseppe Lauria1 1Department of Emergency Medicine, S. Croce e Carle Hospital, Cuneo; 2Department of Emergency Medicine, SS Annunziata Hospital, Savigliano; 3School of Emergency Medicine, University of Turin, Turin; 4Department of Emergency Medicine, Edoardo Agnelli Hospital, Pinerolo, Italy Correspondence: Jacopo Davide Giamello, Department of Emergency Medicine, S. Croce e Carle Hospital, Via Michele Coppino 26, Cuneo, Italy. E-mail: jacopo.giamello@gmail.com Key words: procedural sedation and analgesia, emergency department. Contributions: all authors contributed to the study's conception and design. Material preparation, data collection, and analysis were per- formed by BL, LG, JDG and SA. The first draft of the manuscript was written by BL, JDG, and SA; all authors commented on previ- ous versions of the manuscript. All authors read and approved the final manuscript. Acknowledgements: Francesco Tripi, Attilio Allione, Nicoletta Artana, Letizia Barutta, Elisa Basile, Emanuele Bernardi, Chiara Bertone, Valentina Beux, Marco Bironzo, Eleonora Bonfanti, Alessia Bono, Daniela Caruso, Fabrizio Corsini, Daniele D’Arrigo, Luca Dutto, Stefania Dutto, Andrea Falcetta, Salvatore Franco, Chiara Fulcheri, Anna Giordan, Giovanna Greco, Elena Maggio, Fabio Morra, Massimo Perotto, Alessia Poggi, Tiziana Ponza, Tania Prinzis, Alessandro Raviolo, Michele Ravotti, Massimo Rega, Gabriele Sobrero, Andrea Tortore, Francesco Tosello. Conflict of interest: the authors declare no potential conflict of inter- est, and all authors confirm accuracy. Funding: the research had no financial support. Ethics approval: the Ethics Committee of Azienda Ospedaliera Santa Croce e Carle approved this study (MED.URG 9). The study is con- formed with the Helsinki Declaration of 1964, as revised in 2013, concerning human and animal rights. Informed consent: all patients participating in this study signed a written informed consent form for participating in this study. Patient consent for publication: written informed consent was obtained from a legally authorized representative(s) for anonymized patient information to be published in this article. Availability of data and material: all data are available in the present article. Received: 31 January 2024. Accepted: 28 May 2024. Early view: 27 June 2024. This work is licensed under a Creative Commons Attribution 4.0 License (by-nc 4.0). ©Copyright: the Author(s), 2024 Licensee PAGEPress, Italy Emergency Care Journal 2024; 20:12339 doi:10.4081/ecj.2024.12339 Publisher's note: all claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. Non -co mmerc ial us e o nly ED, tracking a record of the efficacy and safety of this procedure in the hands of EPs.10 Materials and Methods We performed a single-center retrospective cohort study using the local procedural sedation registry. Data were collected for all patients undergoing PSA during the period between January 2015 and December 2020, in the ED of Santa Croce e Carle Hospital, a teaching hospital in Cuneo, north-west Italy. Population Among the total number of patients registered in the informatic database of our ED over the 8 years (about 77.000/year), we select- ed all patients who received at least one of the main four drugs used for PSA: midazolam, propofol, ketamine, fentanyl. We also recorded the use of morphine and ketorolac in this contest. Pregnant women and patients younger than 18 years were exclud- ed. By manual check of medical records, we also excluded patients for whom these drugs had been used solely for analgesic reasons, to treat agitation or psychosis, or to prepare airway intubation. A few records contained incomplete data and were also excluded. The fasting state was not an exclusion criterion.10 For the remain- ing group of patients undergoing PSA, we analyzed the type of procedure performed, the type, dose, and combination of sedatives and analgesics used, the procedural success rate, the adverse events, and the need for rescue interventions. The physical status of the study population was defined before PSA, following the American Society of Anesthesiologists (ASA) physical status classification system (Table 1).10,11 PSA protocol Data of every PSA were registered into a local procedural sedation form. All procedures were performed by EPs alone; the teams included at least one ED nurse and one EP with expertise in PSA conduction, airway management, and cardiovascular and air- way management techniques, as required by the American College of Emergency Physicians (ACEP).4 All procedures were per- formed in a shock room, set up with a monitor and a ventilator, with airway and full resuscitation equipment readily available. In addition, for the management of adverse events, antidotes such as flumazenil and naloxone were available. A protocol concerning the selection and preparation of patients (such as ASA class and difficult airway assessment), equipment and monitoring requirements, and staff training and competency verification was used for all patients. During the procedure, Blood Pressure (BP), Respiratory Rate (RR), Pulse Oximetry (SatO2), Heart Rate (HR), and ECG track were recorded. The end-tidal CO2 monitoring (ETCO2) was not used since it was only recently intro- duced in our setting. Depth of sedation and fasting state were not registered in all patients. Every single EP was responsible for pre- procedure assessment, sedation plan, drug choice and dosing, and monitoring of the patient. Monitorization was discontinued when the level of consciousness returned to before sedation, vital signs were stable, and patients had no pain. In all cases, patients were discharged or transferred after a minimum of 2 hours from the pro- cedure. Definition of adverse effects and PSA failure Adverse events during PSA were defined, following the classi- fication of the World Society for Intravenous Anaesthesia (SIVA) International Sedation Task Force (ISTF),10,12,13 as minimal, minor and major (Table 2). A one-sided binomial test (considering an adverse events incidence of 0.01) was used to report the occur- rence of adverse events in the study. The need for respiratory sup- port with a self-expanding balloon during PSA was not considered an adverse event because it is a possible and predictable conse- quence of deep sedation. Desaturation was hence reported in the adverse events section of our register only when it required mechanical respiratory support or was unexpected or prolonged. PSA failure was defined as the need to resort to anaesthesio- logic assistance for the need to add further sedative drugs or for supportive management. Analysis Clinical and procedural data from the PSA paper form were entered into a database. Categorical variables are expressed as numbers (percentages) and continuous ones as median (25th per- centile; 75th percentile). Statistical analyses were performed by the JASP software. This study was performed under the Declaration of Helsinki and was approved by the local ethics committee. Results 384 potentially painful procedures were performed using PSA in our ED. The median age of patients undergoing PSA was 61 [42;76] years and 239 patients (62.2%) were male. All patients were in a low or medium ASA risk class and most of them were in ASA class I (Table 3). The majority of procedures requiring PSA were orthopedic (206, 53.7%), mainly fractures and dislocation Article [page 100] [Emergency Care Journal 2024; 20:12339] Table 1. American Society of Anesthesiologists classification, adapted from American Society of Anesthesiologists. ASA I A normal healthy patient. Example: Fit, BMI under 30, nonsmoking. ASA II A patient with a mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker or is a cigarette smoker). ASA III A patient with a severe systemic disease that is not life-threatening. Example: Patient with some functional limitation as a result of disease (e.g., poorly treated hypertension or diabetes, morbid obesity, chronic renal failure, a bronchospastic disease with intermittent exacerbation, stable angina, implanted pacemaker). ASA IV A patient with a severe systemic disease that is a constant threat to life. Example: Patient with functional limitation from severe, life-threatening disease (e.g., unstable angina, poorly controlled COPD, symptomatic CHF, recent (less than three months ago) myocardial infarction or stroke. ASA V A moribund patient who is not expected to survive without the operation. The patient is not expected to survive beyond the next 24 hours without surgery. Examples: ruptured abdominal aortic aneurysm, massive trauma, and extensive intracranial hemorrhage with mass effect. ASA VI A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient Non -co mmerc ial us e o nly reductions, followed by Electrical Cardioversions (ECV; 103, 26.8%). The remaining procedures were 75 (19.5%) and have been grouped under the name ‘other procedures’: these included abscess drainage, radiological examinations, and painful medical proce- dures like thoracic drainages or wound medication. The number of procedures carried out each year gradually increased over the years (47 in 2015, 36 in 2016, 29 in 2017, 59 in 2018, 107 in 2019, and 106 in 2020 ), with a substantial overlap in the percentage of indi- cations. Data about drugs used for PSA are reported in Table 4. For 132 patients (34.3%) PSA was performed using a unique drug, mostly midazolam (83 patients, 21.6%), followed by fentanyl (36 patients, 9.4%), and propofol (13 patients, 3.4%). In most patients (252, 65.7%) two or more drugs were associated, with different combi- nations. The preferred drug association was midazolam + fentanyl (186 patients, 48.4%). Midazolam as a monotherapy was mostly used for other proce- dures (67% of cases), but also for orthopedic procedures (19,5% of cases) and ECV (13,5% of cases). The dose of midazolam decreased progressively during the study period (from 10 mg per patient in 2015 to 4 mg in 2020), while its use as a unique drug for PSA increased, contrarily to the use of propofol and fentanyl alone, which decreased through the years. Propofol alone was used in 53% of cases for ECV and in 47% of cases for orthopedic proce- dures. Fentanyl as a monotherapy was mostly used for orthopedic (67% of cases) and other procedures (31% of cases). The association midazolam + fentanyl was used in patients with a median age of 57 years old and mostly for orthopedic pro- cedures (73% of cases), while its use was less frequent for ECV (25% of cases) and other procedures (2% of cases). The utilization of this combination of drugs progressively increased through the study years, passing from 21.7% of total procedures in 2015 to 52.3% of total procedures in 2020. The average dose used for each procedure was 8,1 mg of midazolam and 71 mcg of fentanyl. The median age of patients who received the association propofol + fentanyl was 61 years, and this combination of drugs was used for orthopedic maneuvers in 58% of cases, for ECV in 37% of cases, and for other procedures in 5% of cases. The average dose used was 83 mg of propofol + 62 mcg of fentanyl. During the study period, the prevalence of use of this drug combination remained stable, as well as the average dose used. The global average dose of midazolam was 8 mg/patient, of fentanyl was 72 micrograms/patient, of propofol was 81 mg/patient. Not enough data were available about the use of Ketamine since it was introduced for PSA in our ED just in the last months of the studied period. PSA failure occurred in 3 cases (1%). No major adverse events occurred in this study. 16 patients (4,2% of the total population, p = 1) experienced minor adverse events due to PSA: in 8 cases (50%) a short period (< 60 seconds) of desaturation was registered, with oxygen saturation always > 75%, in 7 cases (44%) hypoten- sion was registered and in 1 case (6%) psychomotor agitation Article [Emergency Care Journal 2024; 20:12339] [page 101] Table 2. Adverse events, adapted from the World Society for Intravenous Anesthesia International Sedation Task Force classification. Description Interventions Outcome Minimal - Vomiting / Retching - No intervention Performed No adverse outcome - Subclinical respiratory depression - Administration of: - Muscle rigidity, myoclonus o Additional sedative(s) - Hypersalivation o Antiemetic - Paradoxical response o Antihistamine - Recovery agitation - Prolonged recovery Minor - Oxygen desaturation (75–90%) for <60s Airway repositioning - Apnoea, not prolonged Tactile stimulation or the administration of - Airway obstruction supplemental oxygen, new or increased; antisialogogue - Failed sedation - Allergic reaction without anaphylaxis - Bradycardia - Tachycardia - Hypotension - Hypertension - Seizure Moderate - Bag valve mask-assisted ventilation Unplanned hospitalization or - Laryngeal mask airway escalation of care - Oral/nasal airway - CPAP - or the administration of: o Reversal agents o Rapid i.v. fluids o Anticonvulsant i.v. Sentinel - Oxygen desaturation, severe - Chest compressions -Death (<75% at any time) or prolonged - Tracheal intubation or the administration of: -Permanent neurological deficit (<90% for >60 s) - Neuromuscular block -Pulmonary aspiration syndrome - Apnoea, prolonged (>60 s) - Pressor /epinephrine - Cardiovascular collapse/ shock - Atropine to treat bradycardia - Cardiac arrest/absent pulse CPAP, Continuous Positive Airway Pressure. Non -co mmerc ial us e o nly occurred. The median age of these patients was 67 years; in 56% (n=9) of cases, adverse events occurred during ECV (8,7 % of all ECV), in 31,2% (n=5) during orthopaedical procedures (2,4% of all orthopaedical procedures) and 12,5% (n=2) of cases during other procedures (2,6% of all other procedures). 12 patients (75%) who experienced minor adverse events were ASA class II and 4 patients (25%) were ASA class I. Most of these patients (10 patients, 62,5%) had received drug associations (Table 5). Compared to the entire cohort, patients who underwent an adverse event significantly differed for ASA class (75% of the patients with adverse events were classified as ASA II, compared to 37.5% in the whole cohort, p<0.05), and for indication (more often ECV; 56.3% vs 26.8%, p <0.05). Discussion PSA is an essential component of the European Core Curriculum for Emergency Medicine proposed for the first time by EUSEM (European Society of Emergency Medicine) in 2002 and subsequently revised in 2017 and 2019 and is considered a core skill for EPs worldwide.3,4,10 Italian emergency medicine-trained physicians have the skills for airway management and ventilation, resuscitation, critical care, monitoring, and pain management3 but they rarely have a well-established track record of safe sedation. This might be one of the reasons why in Italy few and incomplete published data exist about the national experience in this setting, but there are other possible reasons. Firstly, the Italian training pro- gram for Emergency Medicine is relatively new, which could mean that research is still in its infancy.6 Secondly, there is incomplete support from the Italian Drugs Agency (AIFA) regarding the use of certain drugs by EPs.14 There are also concerns about excessive sedation,15 and some doctors may continue to favor short proce- dures performed in the operating room under general anesthesia, or in the emergency department without adequate analgesia or seda- tion.5 To address these issues, we have set out to create the first Italian record of PSA indications, policy, and safety. This study demonstrates that the use of PSA significantly increased in our ED during the studied period, as a likely consequence of the increasing expertise of EPs in managing patients who need PSA. During the last few years, the use of PSA has not only increased for orthopedic procedures or ECV but also for common painful procedures such as radiological examinations or abscess drainage. A continuous growth of this technique is expected in the future years, thanks to the increase of PSA experience among the Italian EPs, leading to better confidence in handling sedative-hypnotic drugs and manag- ing side effects. Italian EPs must receive increasingly greater train- ing on PSA, which must be part of the training curriculum; further- more, these skills must be tested periodically with specific refresh- er sessions. Through time, thanks to the increasing experience in PSA, the average dose of many drugs had a descending trend. In most cases, polypharmacy was preferred. The association midazolam + fen- tanyl was the most used association in our study and was mostly preferred for orthopedic procedures. EPs may have chosen to administer a combination of these drugs due to the availability of their respective antidotes. In case of side effects, especially in older patients, the rapid reversal of midazolam’s effect can be achieved with flumazenil, while the effect of fentanyl can be quickly reversed with naloxone. This could have been a reassuring factor for the physicians. The lower use of propofol compared to midazo- lam in our study, both as a monotherapy or in association with fen- tanyl, differs from what is described in the literature, which reports propofol alone or associated with other analgesics as the most commonly administered medication for PSA.18,19 One of the rea- sons for this choice could be the increased use of PSA for abscess- es drainage, painful medical procedures (e.g. wound medication) or to facilitate radiological examinations. These procedures require longer sedation time than ECV and orthopedic maneuvers and may be better covered by the longer half-life of midazolam.4,20 Another reason is AIFA’s regulatory incomplete support for the use of propofol by non-anaesthesiologists. In any case, no restrictions are Article Table 3. Patients baseline characteristics. Characteristics of patients n = 384 (%) Age (years) 61 [42;76] Male 239 (62.2) ASA class I 239 (62.2) ASA class II 144 (37.5) ASA class III 1 (0.3) PSA indication Orthopaedical procedures 206 (53.7) Electrical cardioversion 103 (26.8) Other procedures 75 (19.5) Adverse events 16 (4) PSA Failings 3 (0.8) Table 4. Patients baseline characteristics. Used drug(s) N (%) Midazolam alone 83 (21.6) Fentanyl alone 36 (9.4) Propofol alone 13 (3.4) Fentanyl + midazolam 186 (48.4) Fentanyl + propofol 44 (11.5) Fentanyl + midazolam + propofol 12 (3.1) Other combinations 10 (2.6) Total monotherapy 132 (34.3) Total polytherapy 252 (65.7) Table 5. Adverse events. Patients with adverse event characteristics n = 16 (% Age 67 [49;77] Adverse events Desaturation 8 (50) Hypotension 7 (44) Psychomotor agitation 1 (6) ASA I 4 (25) ASA II 12 (75) PSA indication Orthopaedical procedures 5 (31.2) Electrical cardioversion 9 (56.3) Other procedures 2 (12.5) Monotherapy 6 (37.5) Polytherapy 10 (62.5) ASA, American Society of Anesthesiologists Classification, PSA, Procedural Sedation and Analgesia. [page 102] [Emergency Care Journal 2024; 20:12339] Non -co mmerc ial us e o nly given about this choice, since studies reporting the use of either midazolam and/or propofol for PSA in the EDs resulted in no significant difference in safety profile and proportion of suc- cessful procedures between agents.21 Of note, in previous studies, propofol required less monitoring and had lower costs than mida- zolam.22 Not enough data were available about ketamine and keto- fol use in this study, due to the late introduction of ketamine for PSA in our ED. Ketamine safety and clinical and procedural advantages over other drugs4,20,23-26 will probably lead to a growth of its use in the next years, which might result in a lower utilization of the other sedatives and analgesics.24-26 It should be noted that also the combination of ketamine and propofol (so-called ketofol) is gaining ground as an effective and safe option for PSA.27 The use of the two drugs allows reducing the doses of each, minimizing potential adverse effects. The use of ketofol has demonstrated a lower incidence of respiratory depression than propofol alone; fur- thermore, the recovery time seems to be significantly shorter.28,29 As previously described, the frequency of adverse events, mainly desaturation and hypotension,30 is low in our study. The median age of patients who experienced adverse events during PSA does not differ from the average age of the total population, as documented also in other studies.19 The majority of adverse events were registered during ECVs. As seen in another study, the prevalence of adverse events increases with the ASA class:19 in our study, the majority of adverse events (75%) occurred in patients with ASA class II while only 4 patients (25%) in ASA class I expe- rienced an adverse event. A slightly greater number of minor adverse events were report- ed in patients who received drug combinations, particularly mida- zolam + fentanyl, compared to single-drug therapy. It is known that drugs in combination differ in times of onset and peak effect so that the effect can be less predictable or difficult to titrate.31 However, the synergic effect of drug combinations, when appro- priately dosed, may allow the administration of lower doses of the single drugs. Due to the small number of adverse events in the total study population, it cannot be determined whether one drug or combina- tion of drugs is associated with a higher rate of minor adverse events than the other. Additionally, it is common for various seda- tives and analgesics used for PSA to cause minor adverse events, which are non-specific.19 Hypoxia is by far the most frequent adverse event described during PSA,4 however, not all studies exclude respiratory support from adverse events as we did, which leads to a difficult compari- son.4 A useful way to further reduce the incidence of hypoxia and desaturation would be the use of capnography,4 which we plan to implement in our clinical practice. In our study, no major adverse events were registered, in line with the very small proportion found in other studies.6,21,30-32 This data and the 99% PSA success rate resulting in our study, support the international evidence on the safety and efficacy of PSA per- formed by adequately trained EPs in the ED.6,9,21,31,32 This study has limitations. Firstly, it was a retrospective, sin- gle-centre study, aiming to describe the current situation in our ED and to produce preliminary data to be confirmed in larger, prospec- tive, multicentre studies. Secondly, data were obtained from med- ical records compiled during ordinary ED activity, which could therefore be incomplete. In addition, the body weight of patients was often unreported, making it impossible to calculate the amount of drugs administered per kg. We were not able to collect vomiting and nausea as adverse events. Furthermore, considering that this is a retrospective study over 8 years, we acknowledge that the casu- istry is low; this is probably due to the delay with which Italian EPs gained experience in PSA. Lastly, the absence of a standardized procedure for drugs and dosages is another limitation of the study. Despite nowadays PSA is usually performed by EPs in Italian EDs, official national guidelines have not yet been established. In 2019, a multicentre interregional prospective study named SEED (Sedation in Emergency Department) was started and is currently ongoing; this study aimed to define a national operating standard that encourages, supports, and regulates PSA performed by EPs in the Italian EDs. Conclusions PSA appeared to be an effective and safe procedure when per- formed by EPs with adequate resuscitation and respiratory support skills, with a high success rate and low incidence of adverse events for patients classified as ASA I-II. In this study, PSA was mostly performed using drug associations, in particular midazolam + fen- tanyl. Larger prospective national studies are needed to define a national operating standard that encourages, supports, and regu- lates EPs performed by PSA in the Italian EDs. References 1. Todd KH, Ducharme J, Choiniere M, et al. Pain in the emer- gency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. PEMI Study Group. 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