Adverse events of procedural sedation and analgesia in a pediatric emergency department*
Study objective: To determine the adverse event and complication rate for the use of procedural sedation and analgesia for painful procedures and diagnostic imaging studies performed in a pediatric emergency department.
Methods: This prospective case series was conducted in the ED of a large, urban pediatric teaching hospital. Subjects were patients younger than 21 years seen between August 1997 and July 1998, who required intravenous, intramuscular, oral, rectal, intranasal, or inhalational agents for painful procedures or diagnostic imaging. All patients who underwent procedural sedation and analgesia were continually monitored. Adverse events and complications were recorded. The ED controlled substance log was checked weekly and all sedations were reviewed. Adverse events were defined as follows: oxygen desaturation less than 90%, apnea, stridor, laryngospasm, bronchospasm, cardiovascular instability, paradoxical reactions, emergence reactions, emesis, and aspiration. Complications were defined as adverse events that negatively affected outcome or delayed recovery.
Results: Of 1,180 patients who underwent procedural sedation and analgesia in the ED, 27 (2.3%) experienced adverse events, which included oxygen desaturation less than 90% requiring intervention (10 patients) [supplemental oxygen (9), bag-mask ventilation (1)], paradoxical reactions (7), emesis (3), paradoxical reaction and oxygen desaturation requiring supplemental oxygen (2), apnea requiring bag-mask ventilation (1), laryngospasm requiring bag-mask ventilation (1), bradycardia (1), stridor and emesis (1) and oxygen desaturation requiring bag-mask ventilation with subsequent emesis (1). There was no statistically significant difference in mean doses for all procedural sedation and analgesia medication regimens between those children who experienced adverse events and those who did not. No single drug or drug regimen was associated with a higher adverse event rate. In addition, there was no significant difference in the adverse event rate between males and females, among the different ages, or among the different indications for procedural sedation and analgesia. No patient required reversal of sedation with naloxone or flumazenil, endotracheal intubation, or hospital admission because of complications from procedural sedation and analgesia.
Conclusion: The adverse event rate for procedural sedation and analgesia performed by pediatric emergency physicians was 2.3% with no serious complications noted.
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Cited by (251)
Practice of sedation-analgesia in emergency departments
2022, Journal Europeen des Urgences et de ReanimationLa sédation-analgésie (S-A) pour la réalisation d’actes douloureux devrait occuper une place importante dans nos pays, au vu de la fréquence de la pathologie traumatologique. Nous avons donc décidé de réaliser une étude pour évaluer les connaissances théoriques et la réalisation pratique des procédures des S-A dans les différents CHU de Libreville.
Étude transversale multicentrique, prospective, observationnelle sur une période de 3 mois et dans 3 CHU de Libreville. Elle comprenait deux parties, une théorique pour évaluer le niveau de connaissance des médecins exerçant au SAU ; et une autre, pratique, dans laquelle les procédures étaient réalisées et évaluées. Les critères d’inclusion étaient : tout médecin exerçant au SAU dans les CHU de Libreville (partie théorique) ; toute personne âgée de plus de 15 ans, devant bénéficier d’une S-A (partie pratique).
Nous avons inclus 44 généralistes (partie théorique) et 40 patients ayant consulté pour une pathologie nécessitant une S-A. Partie théorique : certains médecins généralistes n’avaient jamais recours à la S-A (21 %). La réduction-contention des lésions orthopédiques était l’indication majoritaire. L’association Kétamine-Midazolam était administrée dans la moitié des cas, mais en posologie excessive dans près de 90,3 % des cas. Partie pratique : seul 3 % des généralistes surveillaient tous les paramètres vitaux, la durée des sédations étaient très élevée, soit environ une demi-heure dans 35 % des cas et plus de 50 min dans 27,5 % des cas. Il n’y avait pas d’effets secondaires majeurs notables, mis à part les hallucinations dans 31,1 % des cas.
Une grande partie des médecins exerçant au SAU n’ont pas la maîtrise des quelques molécules qu’ils administrent pour la S-A de geste douloureux, et, n’appliquent pas les mesures de sécurité élémentaires recommandées par les sociétés savantes. Une formation sur sa pratique, et les mesures de sécurité entourant cette procédure devraient être fournies aux différents médecins exerçant aux SAU.
Sedation-analgesia (S-A) for performing painful acts should occupy an important place in our countries, given the frequency of trauma. We therefore decided to carry out a study to evaluate the theoretical knowledge and the practical realization of the procedures of S-A in the different university hospitals of Libreville.
Multicentric, prospective, observational cross-sectional study over a period of 03 months and in 03 University Hospitals of Libreville. Our study included two parts, a theoretical one to assess the level of knowledge of physicians practicing in the ER; and another, practical, in which the procedures were carried out and evaluated. The inclusion criteria were: all doctors practicing in the ER in the university hospitals of Libreville (theoretical part); anyone over the age of 15, who must benefit from an S-A (practical part).
We included 44 general practitioners (theoretical part) and 40 patients who consulted for a pathology requiring S-A. Theoretical part: some general practitioners had never used AS (21%). The reduction-containment of orthopedic lesions was the main indication. The Ketamine-Midazolam association was administered in half of the cases, but in excessive dosage in nearly 90.3% of the cases. Practical part: only 3% of GPs monitored all vital parameters, the duration of sedation was very long, around half an hour in 35% of cases and more than 50 min in 27.5% of cases. There were no notable major side effects, apart from hallucinations in 31.1% of cases.
A large number of physicians practicing in the SAU do not have control of the few drugs they administer for painful gesture S-A, and do not apply the basic safety measures recommended by scientific societies. Training on its practice, and the safety measures surrounding this procedure, should be provided to the various physicians practicing in the SAU.
Predictors of Laryngospasm During 276,832 Episodes of Pediatric Procedural Sedation
2022, Annals of Emergency MedicineLaryngospasm is a rare but potentially life-threatening complication of sedation. The objective of this study was to perform a predictor analysis of biologically plausible predictors and the interventions and outcomes associated with laryngospasm.
Secondary analysis of prospectively collected data from consecutively sedated patients, less than or equal to 22 years of age, at multiple locations at 64 member institutions of the Pediatric Sedation Research Consortium. The primary outcome was laryngospasm. The independent variables in the multivariable model included American Society of Anesthesiologists category, age, sex, concurrent upper respiratory infection, medication regimen, hospital sedation location, whether the procedure was painful, and whether the procedure involved the airway. The analysis included adjusted odds ratios (aORs) and predicted probabilities.
We analyzed 276,832 sedations with 913 reported events of laryngospasm (overall unadjusted prevalence 3.3:1,000). A younger age, a higher American Society of Anesthesiologists category, a concurrent upper respiratory infection (aOR 3.94, 2.57 to 6.03; predicted probability 12.2/1,000, 6.3/1,000 to 18.0/1,000), and airway procedures (aOR 3.73, 2.33 to 5.98; predicted probability 9.6/1,000, 5.2/1,000 to 13.9/1,000) were associated with increased risk. Compared with propofol alone, propofol combination regimens had increased risk (propofol+ketamine: aOR 2.52, 1.41 to 4.50; predicted probability 7.6/1,000, 3.1/1,000 to 12/1,000; and propofol+dexmedetomidine: aOR 2.10, 1.25 to 3.52; predicted probability 6.3/1,000, 3.7,/1,000 to 8.9/1,000). Among patients with laryngospasm, the resulting outcomes included desaturation less than 70% for more than 30 seconds (19.7%), procedure not completed (10.6%), emergency airway intervention (10.0%), endotracheal intubation (5.3%), unplanned admission/increase in level of care (2.3%), aspiration (1.1%), and cardiac arrest (0.2%).
We found increased associations of laryngospasm in pediatric procedural sedation with multiple biologic factors, procedure types, and medication regimens. However, effect estimates showed that the laryngospasm prevalence remained low, and this should be taken into consideration in sedation decisionmaking.
Virtual Reality as Anxiolysis During Laceration Repair in the Pediatric Emergency Department
2022, Journal of Emergency MedicineAlthough procedural pain is effectively treated with analgesics, managing anxiety during laceration repair is more challenging.
We examined the feasibility of using immersive virtual reality (VR) as anxiolysis during laceration repair in the pediatric emergency department (ED).
We conducted a non-blinded, observational, pilot study in an urban pediatric ED that enrolled a convenience sample of children aged 5–13 years undergoing sutured repair of non-facial lacerations. Subjects played an immersive VR game while undergoing laceration repair. Parents assessed their child's anxiety on a 100-mm visual analogue scale at enrollment and during laceration repair. The primary outcome measure was the percentage of children whose anxiety score did not increase by ≥ 20 mm from enrollment to the first stitch.
Forty patients completed the study. Mean initial anxiety score was 54 mm (standard deviation 33 mm). Thirty-seven of forty patients (93%; 95% confidence interval [CI] 83–99%) had anxiety scores that did not increase by 20 mm or more from enrollment to the first stitch. Eighty percent (95% CI 64–91%) of patients’ anxiety scores decreased between enrollment and first stitch. The mean change in anxiety score at first stitch was −39 mm (95% CI −51 mm to −27 mm; p < 0.001). Similar downward trends in anxiety scores were noted throughout the procedure. All laceration repairs were successfully completed without sedation or restraints. There were no adverse events noted, and the main barriers identified with VR use involved easily correctable technical difficulties with the equipment.
Immersive VR is a safe and effective distractive technique to reduce procedural anxiety during laceration repair in the pediatric ED.
Assessment of the practice of pediatrics procedural sedation and analgesia for magnetic resonance imaging and computed tomography scan at a teaching hospital, Ethiopia, 2020: A clinical audit
2021, Journal of Medical Imaging and Radiation SciencesThe main goals of paediatric sedation/general anesthesia vary according to the specific imaging procedure, but generally includes anxiety relief, pain control and control of excessive movement. The quality of magnetic resonance imaging (MRI) and computed tomography (CT) depends largely on immobility of the patient during the procedure, which is often difficult to achieve without sedation in children. Sedation is the depression of the central nervous system and reflexes by the administration of drugs. Brain imaging is routinely used to identify stroke, hemorrhage, and structural abnormalities. All patients undergoing procedural sedation and those receiving general anesthesia should be evaluated equally.
The study aimed to perform a clinical audit of sedation and analgesia practices for magnetic resonance imaging and computed tomography compared against the guidelines/standards to determine if practice meets the standards and identify areas of non-compliance at a teaching Referral Hospital in Ethiopia.
This clinical audit was conducted from January 1 to May 30/2020 for 5 months at a teaching Referral Hospital in Ethiopia. All children below the age of 6 years underwent MRI and CT imaging procedures under sedation during a study period were included. Data were collected through direct observation using checklists of standards by a trained data collector. Descriptive statistics were presented with tables, graphs of sums and percentages of items using SPSS version 20.
A total of 40 children underwent MRI and CT imaging were observed at the Hospital imaging sites. Among the 20 standards, 6 of them had 100% compliance rate, 3 of the standards had 0% complaince rate and 11 of the standards had the compliance rate of between 0 and 100%.
In general, even though the practice guidelines of procedural sedation for MRI and CT recommend to practice procedures based on the standards, this study showed there were a number of standards that had <100% compliance rate. Therefore, it is recommended that staff should adopt standards or locally prepared protocols for their day-to-day practice.
Les principaux objectifs de la sédation ou de/anesthésie générale pédiatrique varient en fonction de la procédure d'imagerie spécifique, mais contiennent généralement le soulagement de l'anxiété, le contrôle de la douleur et la maîtrise des mouvements excessifs. La qualité de l'imagerie par résonance magnétique (IRM) et de la tomodensitométrie (CT) dépend largement de l'immobilité du patient pendant l'intervention, qui est souvent difficile à obtenir sans sédation chez les enfants. La sédation est la dépression du système nerveux central et des réflexes par l'administration de médicaments. L'imagerie cérébrale est couramment utilisée pour identifier les accidents vasculaires cérébraux, les hémorragies et les anomalies structurelles. Tous les patients sous sédation procédurale et ceux qui reçoivent une anesthésie générale doivent être évalués de la même façon.
L'étude visait à réaliser un audit clinique des pratiques de sédation et d'analgésie pour l'imagerie par résonance magnétique et la tomodensitométrie par rapport aux lignes directrices/normes afin de déterminer si la pratique répond aux normes et d'identifier les domaines de non-conformité dans un hôpital universitaire de référence en Éthiopie.
Cet audit clinique a été mené sur une période de 5 mois, du 1er janvier au 30 mai 2020, dans un hôpital universitaire de référence en Éthiopie. Tous les enfants de moins de 6 ans ayant subi des procédures d'IRM et d'imagerie CT sous sédation pendant une période d'étude ont été inclus. Les données ont été recueillies par observation directe à l'aide de listes de contrôle des normes par un collecteur de données formé. Des statistiques descriptives ont été présentées avec des tableaux, des graphiques de sommes et de pourcentages d'éléments en utilisant la version 20 de SPSS.
Au total, 40 enfants ont subi une IRM ou une tomodensitométrie sur les sites d'imagerie de l'hôpital. Parmi les 20 normes, six avaient un taux de conformité de 100%, trois avaient un taux de plainte de 0% et 11 avaient un taux de conformité entre 0 et 100 %é.
En général, même si les directives de pratique de la sédation procédurale pour l'IRM et la TDM recommandent de pratiquer des procédures basées sur les normes, cette étude a montré qu'il y avait un certain nombre de normes qui avaient un taux de conformité inférieur à 100%. Par conséquent, nous voudrions recommander que le personnel ait adopté des normes ou des protocoles préparés localement pour sa pratique quotidienne.
Adverse events and satisfaction with use of intranasal midazolam for emergency department procedures in children
2019, American Journal of Emergency MedicineProcedural sedation is commonly performed in the emergency department (ED). Having safe and fast means of providing sedation and anxiolysis to children is important for the child's tolerance of the procedure, parent satisfaction and efficient patient flow in the ED.
To evaluate fasting times associated with the administration of intranasal midazolam (INM) and associated complications. Secondary objectives included assessing provider and caregiver satisfaction scores.
A prospective observational study was conducted in children presenting to an urban pediatric emergency department who received INM for anxiolysis for a procedure or imaging. Data collected included last solid and liquid intake, procedure performed, sedation depth, adverse events and parent and provider satisfaction.
112 patients were enrolled. The mean age was 3.8 years. There were no adverse events experienced by any patients. Laceration repair was the most common reason for INM use. The median depth of sedation was 2.0 (cooperative/tranquil). The median liquid NPO time was 172.5 min and the median NPO time for solids was 194.0 min. 29.8% were NPO for liquids ≤2 h and 62.5% were NPO for solids ≤2 h. Parent and provider satisfaction was high: 90.4% of parents' and 88.4% of providers' satisfaction scores were a 4 or 5 on a 5 point Likert scale.
Our data suggest that short NPO of both solids and liquids are safe for the use of INM. Additionally, parent and provider satisfaction scores were high with the use of INM.
Efficacy, safety and satisfaction of sedation-analgesia in Spanish emergency departments
2019, Anales de PediatriaLa sedoanalgesia debe ser una prioridad de los servicios de urgencias pediátricas. Analizamos la eficacia y seguridad de los procedimientos de sedoanalgesia así como la satisfacción del personal, pacientes y padres.
Estudio multicéntrico, prospectivo, observacional y analítico de los procedimientos de sedoanalgesia realizados a niños hasta los 18 años en 18 servicios de urgencias entre febrero de 2015 y enero de 2016.
Se registraron 658 procedimientos (edad media: 6,8; DE: 4 años). La eficacia fue buena en 483 niños (76,1%; IC 95%: 72,7-79,4%), parcial en 138 (21,7%; IC 95%: 18,5-24,9%) y mala en 14 (2,2%; IC 95%: 1,1-3,4). Se asoció con eficacias mejores la realización por el pediatra de urgencias (OR: 3,14; IC 95%: 1,10-8,95) y un mayor nivel de sedación alcanzado (OR: 2,37; IC 95%: 1,68-3,35). Presentaron eventos adversos precoces 52 (8,4%) niños, siendo los más frecuentes: digestivos, neurológicos y respiratorios (el 89,9% remitieron en < 2 h). Un paciente requirió intubación. La mayor edad y la mayor profundidad de sedación fueron factores de riesgo independientes para presentar eventos adversos (OR: 1,18; IC 95%: 1,09-1,28 y OR: 1,86; IC 95%: 1,22-2,83, respectivamente). Trece niños (5%) presentaron eventos adversos tardíos, siendo el mareo y las náuseas/vómitos los más frecuentes; en todos ellos se usó la combinación midazolam/ketamina (RR: 24,46; IC 95%: 11,78-50,76). Registramos la satisfacción percibida (puntuación de 0-10) de 604 profesionales (media: 8,54, DE: 1,95), de 526 padres (media: 8,86; DE: 1,49) y de 402 niños (media: 8,78; DE: 1,70).
Los procedimientos de sedoanalgesia realizados por profesionales entrenados en los servicios de urgencias pediátricas españoles resultan útiles, eficaces y seguros, además de satisfactorios para todos los participantes.
To offer analgesia and sedation should be a priority in paediatric emergency departments. The aim of this study was to determine the effectiveness and safety of the sedation-analgesia procedure, as well as the satisfaction of the doctors, patients and parents.
A multicentre, observational, and prospective analytical study was conducted on the sedation-analgesia procedure performed on children younger than 18 years old in 18 paediatric emergency departments in Spain from February 2015 until January 2016.
A total of 658 procedures were recorded. The effectiveness was good in 483 cases (76.1%; 95% CI: 72.7-79.4%), partial in 138 (21.7%; 95% CI: 18.5-24.9%), and poor in 14 (2.2%; 95% CI: 1.1-3.4). The effectiveness was better when the doctor in charge was an emergency paediatrician (OR: 3.14; 95% CI: 1.10-8.95), and when a deeper level of sedation was achieved (OR: 2.37; 95% CI: 1.68-3.35). Fifty two children (8.4%) developed adverse drug reactions, more usually gastrointestinal, neurological or respiratory ones (89.9% were resolved in < 2 h). One patient was intubated. The older child and a deeper level of sedation were found to be independent risk factors for adverse reactions (OR: 1.18; 95% CI: 1.09-1.28 and OR: 1.86; 95% CI: 1.22-2.83, respectively). Thirteen children (5%) developed late adverse drug reactions, more commonly, dizziness and nauseas. A combination of midazolam/ketamine had been used in all the cases (RR: 24.46; 95% CI: 11.78-50.76). The perceived satisfaction level (0-10) was obtained from 604 doctors (mean: 8.54; SD: 1.95), 526 parents (mean: 8.86; SD: 1.49), and 402 children (mean: 8.78; SD: 1.70).
The sedation-analgesia procedure performed in paediatric emergency departments by trained paediatricians seems to be useful, effective and safe, as well as satisfactory for all participants.
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Presented at the American Academy of Pediatrics annual meeting, San Francisco, CA, October 1998.