Association of ketamine use during procedural sedation with oxygen desaturation and healthcare utilisation: a multicentre retrospective hospital registry study.

BACKGROUND: We investigated the effects of ketamine on desaturation and the risk of nursing home discharge in patients undergoing procedural sedation by anaesthetists. METHODS: We included adult patients who underwent procedures under monitored anaesthetic care between 2005 and 2021 at two academic healthcare networks in the USA. The primary outcome was intraprocedural oxygen desaturation, defined as oxygen saturation <90% for ≥2 consecutive minutes. The co-primary outcome was a nursing home discharge. RESULTS: Among 234,170 included patients undergoing procedural sedation, intraprocedural desaturation occurred in 5.6% of patients who received ketamine vs 5.2% of patients who did not receive ketamine (adjusted odds ratio [ORadj] 1.22, 95% confidence interval [CI] 1.15-1.29, P<0.001; adjusted absolute risk difference [ARDadj] 1%, 95% CI 0.7-1.3%, P<0.001). The effect was magnified by age >65 yr, smoking, or preprocedural ICU admission (P-for-interaction <0.001, ORadj 1.35, 95% CI 1.25-1.45, P<0.001; ARDadj 2%, 95% CI 1.56-2.49%, P<0.001), procedural risk factors (upper endoscopy of longer than 2 h; P-for-interaction <0.001, ORadj 2.91, 95% CI 1.85-4.58, P<0.001; ARDadj 16.2%, 95% CI 9.8-22.5%, P<0.001), and high ketamine dose (P-for-trend <0.001, ORadj 1.61, 95% CI, 1.43-1.81 for ketamine >0.5 mg kg-1). Concomitant opioid administration mitigated the risk (P-for-interaction <0.001). Ketamine was associated with higher odds of nursing home discharge (ORadj 1.11, 95% CI 1.02-1.21, P=0.012; ARDadj 0.25%, 95% CI 0.05-0.46%, P=0.014). CONCLUSIONS: Ketamine use for procedural sedation was associated with an increased risk of oxygen desaturation and discharge to a nursing home. The effect was dose-dependent and magnified in subgroups of vulnerable patients.

Procedural sedation competencies: a review and multidisciplinary international consensus statement on knowledge, skills, training, and credentialing.

Procedural sedation is practised by a heterogeneous group of practitioners working in a wide array of settings. However, there are currently no accepted standards for the competencies a sedation practitioner should have, the content of sedation training programmes, and guidelines for credentialing. The multidisciplinary International Committee for the Advancement of Procedural Sedation sought to develop a consensus statement on the following: which competencies should medical or dental practitioners have for procedural sedation and how are they obtained, assessed, maintained, and privileged. Using the framework of Competency-Based Medical Education, the practice of procedural sedation was defined as a complex professional task requiring demonstrable integration of different competencies. For each question, the results of a literature review were synthetised into preliminary statements. Following an iterative Delphi review method, final consensus was reached. Using multispeciality consensus, we defined procedural sedation competence by identifying a set of core competencies in the domains of knowledge, skills, and attitudes across physical safety, effectiveness, psychological safety, and deliberate practice. In addition, we present a standardised framework for competency-based training and credentialing of procedural sedation practitioners.

Pharmacological agents for procedural sedation and analgesia in the emergency department and intensive care unit: a systematic review and network meta-analysis of randomised trials.

BACKGROUND: We aimed to evaluate the comparative effectiveness and safety of various i.v. pharmacologic agents used for procedural sedation and analgesia (PSA) in the emergency department (ED) and ICU. We performed a systematic review and network meta-analysis to enable direct and indirect comparisons between available medications. METHODS: We searched Medline, EMBASE, Cochrane, and PubMed from inception to 2 March 2023 for RCTs comparing two or more procedural sedation and analgesia medications in all patients (adults and children >30 days of age) requiring emergent procedures in the ED or ICU. We focused on the outcomes of sedation recovery time, patient satisfaction, and adverse events (AEs). We performed frequentist random-effects model network meta-analysis and used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to rate certainty in estimates. RESULTS: We included 82 RCTs (8105 patients, 78 conducted in the ED and four in the ICU) of which 52 studies included adults, 23 included children, and seven included both. Compared with midazolam-opioids, recovery time was shorter with propofol (mean difference 16.3 min, 95% confidence interval [CI] 8.4-24.3 fewer minutes; high certainty), and patient satisfaction was better with ketamine-propofol (mean difference 1.5 points, 95% CI 0.3-2.6 points, high certainty). Regarding AEs, compared with midazolam-opioids, respiratory AEs were less frequent with ketamine (relative risk [RR] 0.55, 95% CI 0.32-0.96; high certainty), gastrointestinal AEs were more common with ketamine-midazolam (RR 3.08, 95% CI 1.15-8.27; high certainty), and neurological AEs were more common with ketamine-propofol (RR 3.68, 95% CI 1.08-12.53; high certainty). CONCLUSION: When considering procedural sedation and analgesia in the ED and ICU, compared with midazolam-opioids, sedation recovery time is shorter with propofol, patient satisfaction is better with ketamine-propofol, and respiratory adverse events are less common with ketamine.

The effect of age on outpatient pediatric procedural sedation with intranasal dexmedetomidine and oral midazolam.

Procedural sedation for diagnostic examination is a common practice in children. The study aims to analyze the sedative effect and safety of intranasal dexmedetomidine combined with oral midazolam in outpatient pediatric procedural sedation across different age groups and to assess the incidence of sedation failure. From February 2021 to September 2021, children who underwent procedural sedation were retrospectively enrolled. The children were divided into 4 groups based on age: the infant group (0 to 1 year old), toddler group (1 to 3 years old), preschool group (3 to 6 years old), and school-age group (6 to 12 years old). Two-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam were used for sedation. The sedation success rate after rescue, sedation success rate, onset time of sedation, and the sedation time were recorded. The incidence of adverse events and the risk factors for sedation failure were also analyzed. A total of 4758 patients were identified. After exclusion, 3149 patients were ultimately enrolled. The combination of 2-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam resulted in a total success rate of 99.7% and a sedation success rate of 91.4%. The sedation success rate varied among the four groups: 90.2% in the infant group, 93.1% in the toddler group, 92.7% in the preschool group, and 78.4% in the school-age group. The sedation success rate was significantly lower in the school-age group compared to the other three groups (P < 0.001). The onset time of sedation was shorter in infant (22 min, IQR: 18-28 min, P < 0.001) and longer in the school-age group (30 min, IQR: 25-35 min, P < 0.05). Additionally, the infants had a longer sedation time (110 min, IQR: 90-135 min, P < 0.001) and a higher rate of delayed recovery (27.5%, all P < 0.001). The incidence of adverse events was low (4.70%), which bradycardia (2.03%) being the most common. Age (0-1 year and > 6 years), weight, ASA class II, and history of failed sedation were identified as risk factors of sedation failure.   Conclusion: Intranasal administration of 2-mcg/kg dexmedetomidine combined with oral administration of 0.5-mg/kg midazolam was found to be efficient and safety for pediatric procedural sedation. Different age groups of children exhibited distinct sedation characteristics, and age was identified as a risk factor affecting the efficacy of sedation. What is Known: • Procedural sedation for diagnostic examination is a common practice in children. • The combination of dexmedetomidine with midazolam can improve sedative effects. What is New: • The success rate of sedation using a combination of 2-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam was significantly lower in school-age children as compared to infants, toddlers, and preschoolers. • The onset time of sedation increased with age, and the sedation time was found to be longer in infant patients.

Procedural sedation and analgesia in Swiss Pediatric Emergency Departments: a national subgroup analysis of a European cross-sectional survey.

This study aims to provide a national overview of procedural sedation and analgesia practices within Pediatric Emergency Departments in Switzerland, focusing on the availability of pharmacologic agents, the presence of safety protocols, the utilization of non-pharmacological interventions, and to identify specific local limitations. We conducted a detailed subgroup analysis of Swiss data from a European cross-sectional survey on emergency department pediatric Procedural Sedation and Analgesia (PSA) practice, isolating data from Swiss sites. The survey, conducted between November 2019 and March 2020, covered various aspects of procedural sedation and analgesia practices. The survey included nine Swiss sites, treating a total of 252,786 patients in 2019. Topical analgesia, inhaled equimolar nitrous oxide-oxygen mixture, and ketamine were largely available. All sites had nurse-directed triage protocols in place; however, opioid administration was included in the protocols in only 66% of sites. Only 33% of hospitals reported common use of intravenous sedation. Barriers to procedural sedation and analgesia implementation included staffing shortages (89% of sites) and lack of dedicated spaces (78%).Conclusions: Despite a broad array of pharmacological and options available in Swiss Pediatric Emergency Departments, challenges remain in standardizing practices across the country. Limited space and staffing and enhancing training on non-pharmacological interventions were identified as potential areas for improving pain and anxiety management in pediatric emergency care. This study underscores the need for national guidelines to harmonize emergency department PSA practices across Switzerland, ensuring all children have access to effective and evidence-based procedural comfort. What is Known: • Recent research, conducted in European emergency departments, suggests that in pediatric Procedural Sedation and Analgesia (PSA) resources are limited, and practice is heterogeneous What is New: • Swiss pediatric hospitals offer a wide range of pharmacological options for pain and anxiety management. However, significant barriers to PSA were identified. These include external control of intravenous sedation and insufficient integration of non-pharmacological interventions, such as child life specialists and procedural hypnosis. National guidelines are needed to harmonize PSA practices.

The clinical role of remimazolam: Protocol for a scoping review.

BACKGROUND: Remimazolam, a novel benzodiazepine, shows promise as an alternative to traditional sedatives and hypnotic agents in procedural sedation and general anaesthesia. While preliminary research indicates potential advantages over conventional agents, such as faster onset, predictable duration, and improved safety profile, the extent and quality of existing evidence remain unclear. This scoping review aims to investigate the current clinical role of remimazolam and provide a broad and comprehensive overview. METHODS: The proposed review will adhere to the JBI methodology for scoping reviews and the Preferred Reporting Items for Systematic Review and Meta-Analysis for Scoping Reviews. A comprehensive search will be conducted across major peer-reviewed databases and grey literature will be sought. All studies involving individuals undergoing procedural sedation or general anaesthesia with remimazolam will be eligible. Data extraction will encompass trial and participant characteristics, intervention details, reported outcomes, comparative efficacy versus midazolam and propofol, patient and operator experience and economic costs. RESULTS: We will provide a descriptive summary supplemented by statistics, figures and tables where applicable. CONCLUSION: The outlined scoping review aims to assess the clinical use of remimazolam in procedural sedation and as the hypnotic component of general anaesthesia. The review will map the current body of evidence of remimazolam and identify knowledge gaps, contributing to understanding its clinical implications and guiding future research efforts in procedural sedation and general anaesthesia.

Effectiveness of pharmacological procedural sedation in children with autism spectrum disorder: A systematic review and meta-analysis.

AIM: Management of primary healthcare and routine minor procedures for children with autism spectrum disorder (ASD) can be challenging; therefore, when behavioural strategies fail, sedative medications are often employed. We evaluated the effectiveness of the current pharmacological strategies for managing children with ASD. METHODS: We performed a systematic review and meta-analysis of the current approaches for procedural sedation in children with ASD. RESULTS: Twenty studies met inclusion criteria. Dexmedetomidine, midazolam, propofol and chloral hydrate were the most efficient agents for successful procedures, while propofol had the highest number of adverse events. The most frequently used agents were dexmedetomidine and midazolam or a combination of the two, and the effectiveness of dexmedetomidine plus midazolam was superior to dexmedetomidine alone. CONCLUSION: Multiple effective drug regimens exist for procedural sedation in children with ASD. These results could support the development of specific guidelines for procedural sedation in children with ASD.

Clinical experience with remimazolam in pediatric anesthesiology: An educational focused review.

Remimazolam is a novel ultrashort-acting benzodiazepine, which like midazolam, results in sedation, anxiolysis, and amnesia through its agonistic effects on the gamma-amino butyric acid A receptor. As opposed to midazolam, its unique metabolism is via tissue esterases, which results in a rapid elimination with a limited context sensitive half-life and prompt dissipation of its effect when administration is discontinued. Remimazolam received FDA approval for use in adults in 2020. In preliminary and initial clinical trials, its efficacy and safety has been suggested in the adult population, both as a primary agent for procedural sedation or as an adjunct to general anesthesia. There are limited data regarding the use of remimazolam in infants and children and its use in this population remains off label as it does not hold FDA-approval in pediatric-aged patients. This narrative outlines the pharmacologic properties of this unique medication, reviews previous published reports of its role in pediatric-aged patients, and discusses dosing parameters and clinical use in this population.

A randomized, double-blind, dose-controlled study of the use of dexmedetomidine alone for procedural sedation of children and adolescents undergoing MRI scans.

BACKGROUND: Dexmedetomidine is a selective α2-adrenergic agonist originally approved for sedation of adults in the intensive care unit and subsequently approved for procedural sedation in adults undergoing medical procedures. Dexmedetomidine is widely used off-label for procedural sedation in children. AIMS: To evaluate efficacy and safety of monotherapy dexmedetomidine for magnetic resonance imaging procedural sedation of children ≥1month-<17years across three ascending doses. METHODS: Randomized, double-blind, dose-ranging study of procedural sedation recruited patients at USA and Japanese sites from February 2020 to November 2021. Patients were stratified into Cohort A (≥1month-<2years) or Cohort B (≥2-<17years). Cohort A loading doses/maintenance infusions: 0.5 mcg/kg/0.5 mcg/kg/h, 1.0 mcg/kg/1.0 mcg/kg/h, and 1.5 mcg/kg/1.5 mcg/kg/h. Cohort B loading doses/maintenance infusions: 0.5 mcg/kg/0.5 mcg/kg/h, 1.2 mcg/kg/1.0 mcg/kg/h, and 2.0 mcg/kg/1.5 mcg/kg/h. Primary endpoint was percentage of overall patients completing MRI without rescue propofol at the high versus low dose. Key secondary endpoint was percentage in each age cohort who did not require propofol at the high versus low dose. RESULTS: One hundred twenty-two patients received high- (n = 38), middle- (n = 42), or low-dose (n = 42) dexmedetomidine. A greater percentage completed MRI without propofol rescue, while receiving high- versus low-dose dexmedetomidine (24/38 [63.2%] vs. 6/42 [14.3%]) (odds ratio: 10.29, 95% confidence interval: 3.47-30.50, p < .001). Similar results were seen in both age cohorts. The most common adverse events were bradypnea, bradycardia, hypertension, and hypotension, and the majority were of mild-to-moderate severity. CONCLUSIONS: Dexmedetomidine was well tolerated. The high dose was associated with meaningfully greater efficacy compared with lower doses. Based on these results, the recommended starting dose for procedural sedation in children ≥1month-<2years is loading dose 1.5 mcg/kg/maintenance infusion 1.5 mcg/kg/h; children ≥2-<17years is loading dose 2.0 mcg/kg/maintenance infusion 1.5 mcg/kg/h.

Automating sedation state assessments using natural language processing.

INTRODUCTION: Common goals for procedural sedation are to control pain and ensure the patient is not moving to an extent that is impeding safe progress or completion of the procedure. Clinicians perform regular assessments of the adequacy of procedural sedation in accordance with these goals to inform their decision-making around sedation titration and also for documentation of the care provided. Natural language processing could be applied to real-time transcriptions of audio recordings made during procedures in order to classify sedation states that involve movement and pain, which could then be integrated into clinical documentation systems. The aim of this study was to determine whether natural language processing algorithms will work with sufficient accuracy to detect sedation states during procedural sedation. DESIGN: A prospective observational study was conducted. METHODS: Audio recordings from consenting participants undergoing elective procedures performed in the interventional radiology suite at a large academic hospital were transcribed using an automated speech recognition model. Sentences of transcribed text were used to train and evaluate several different NLP pipelines for a text classification task. The NLP pipelines we evaluated included a simple Bag-of-Words (BOW) model, an ensemble architecture combining a linear BOW model and a "token-to-vector" (Tok2Vec) component, and a transformer-based architecture using the RoBERTa pre-trained model. RESULTS: A total of 15,936 sentences from transcriptions of 82 procedures was included in the analysis. The RoBERTa model achieved the highest performance among the three models with an area under the ROC curve (AUC-ROC) of 0.97, an F1 score of 0.87, a precision of 0.86, and a recall of 0.89. The Ensemble model showed a similarly high AUC-ROC of 0.96, but lower F1 score of 0.79, precision of 0.83, and recall of 0.77. The BOW approach achieved an AUC-ROC of 0.97 and the F1 score was 0.7, precision was 0.83 and recall was 0.66. CONCLUSION: The transformer-based architecture using the RoBERTa pre-trained model achieved the best classification performance. Further research is required to confirm the that this natural language processing pipeline can accurately perform text classifications with real-time audio data to allow for automated sedation state assessments. CLINICAL RELEVANCE: Automating sedation state assessments using natural language processing pipelines would allow for more timely documentation of the care received by sedated patients, and, at the same time, decrease documentation burden for clinicians. Downstream applications can also be generated from the classifications, including for example real-time visualizations of sedation state, which may facilitate improved communication of the adequacy of the sedation between clinicians, who may be performing supervision remotely. Also, accumulation of sedation state assessments from multiple procedures may reveal insights into the efficacy of particular sedative medications or identify procedures where the current approach for sedation and analgesia is not optimal (i.e. a significant amount of time spent in "pain" or "movement" sedation states).

Integrated pulmonary index during procedural sedation and analgesia: A cluster-randomized trial.

AIM: To evaluate the effectiveness of utilizing the integrated pulmonary index for capnography implementation during sedation administered by nurses. DESIGN: Cluster-randomized trial. METHODS: Participants were enrolled from the interventional radiology department at an academic hospital in Canada. Nurses were randomized to either enable or disable the Integrated Pulmonary Index feature of the capnography monitor. Procedures were observed by a research assistant to collect information about alarm performance characteristics. The primary outcome was the number of seconds in an alert condition state without an intervention being applied. RESULTS: The number of seconds in an alarm state without intervention was higher in the group that enabled the integrated pulmonary index compared to the group that disabled this feature, but this difference did not reach statistical significance. Likewise, the difference between groups for the total alarm duration, total number of alarms and the total number of appropriate alarms was not statistically significant. The number of inappropriate alarms was higher in the group that enabled the Integrated Pulmonary Index, but this estimate was highly imprecise. There was no difference in the odds of an adverse event (measured by the Tracking and Reporting Outcomes of Procedural Sedation tool) occurring between groups. Desaturation events were uncommon and brief in both groups but the area under the SpO2 90% desaturation curve scores were lower for the group that enabled the integrated pulmonary index. CONCLUSION: Enabling the integrated pulmonary index during nurse-administered procedural sedation did not reduce nurses' response times to alarms. Therefore, integrating multiple physiological parameters related to respiratory assessment into a single index did not lower the threshold for intervention by nurses. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The time it takes to respond to capnography monitor alarms will not be reduced if the integrated pulmonary Iindex feature of capnography monitors is enabled during nurse-administered procedural sedation. IMPACT: Results do not support the routine enabling of the integrated pulmonary index when nurses use capnography to monitor patients during procedural sedation as a strategy to reduce the time it takes to initiate responses to alarms. REPORTING METHOD: CONSORT. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution. TRIAL REGISTRATION: This study was prospectively registered at ClinicalTrials.gov (ID: NCT05068700).

Association between pre-procedural anxiety and vomiting in children who undergo procedural sedation and analgesia in the emergency department.

INTRODUCTION: Children presenting to the emergency department (ED) often require procedural sedation and analgesia (PSA) prior to procedures. Although ketamine is used widely for PSA safely, there is a risk of adverse effects. Among them, vomiting is significant as it occurs in about 10% of patients and can potentially endanger the airway. Because there is evidence that post-operative complications might be due to anxiety prior to the operation, this study aims to investigate the association between pre-procedural anxiety and vomiting in the ED. METHODS: In this cohort study, a convenient sample of children aged 2 to 14 years who were a candidate for PSA with ketamine in the ED were enrolled. Anxiety was evaluated using the short version of the modified Yale preoperative anxiety scale (mYAS). Vomiting was recorded during the period of hospitalization in the ED and 24 h after discharge by a phone call. Association between anxiety level and vomiting was analyzed using the independent samples t-test and multivariable logistic regression was used to control for covariates. RESULTS: 102 children were enrolled and 93 were included in final analysis. The mean age of participants was 3.95 ± 1.79 years and 55.9% were male. According to the mYAS, the mean score of anxiety was 48.67 ± 21.78 in the waiting room and 59.10 ± 23.86 in the operating room. The mean score of anxiety was 58.3±25.3 and 51.0±20.7 in the vomiting and non-vomiting groups, respectively. At least one episode of vomiting was reported in 23 children of which, 19 took place in the hospital and 4 after discharge. No significant association was observed between pre-procedural anxiety and the occurrence of vomiting. On univariate regression model, the odds ratio of the association between mean anxiety and vomiting was 1.02 (CI 95%: 0.99-1.04) (P-value: 0.16). On the multivariable logistic regression model, after adjusting for all the covariates, the odds ratio was 1.03 (CI 95%: 1.0-1.05) (P-value: 0.05). CONCLUSION: The present study showed that anxiety before procedural sedation and analgesia with ketamine in children was not associated with the incidence of vomiting.

Design Specifications for an Automated System to Deliver Instructions About Preprocedure Fasting.

PURPOSE: Many patients undergoing surgical and other medical procedures requiring sedation or anesthesia receive standardized "no eating or drinking after midnight" instructions. This "standardized" instruction does not change regardless of potential alterations in scheduling that result in significant delays in procedure start times. As a result, the duration of preprocedure fasting often far exceeds recommended requirements. A technological solution that automates the delivery of preprocedure fasting instructions to patients would likely improve the patient experience. The purpose of this study was to determine design specifications for the delivery of notifications to patients as part of an automated system. DESIGN: A qualitative study was conducted with 14 adult participants using the persona-scenario method. METHODS: Participants worked in groups to create realistic but fictitious personas and scenarios that described how individuals like themselves would interact with an automated preprocedure fasting instruction system. Data generated through the development of the scenarios were analyzed to first identify important themes, which were then interpreted into design specifications. FINDINGS: Seven women and seven men, aged 25 to 75, developed 9 persona-scenarios, which captured outpatient and inpatient preprocedure fasting experiences, as well as perspectives of individuals who were not comfortable with technology, or those for which English was not the primary spoken language. Most scenarios described preprocedure fasting instructions delivered by an automated bidirectional short message service system. Two major themes were identified as patient priorities, including: (1) enhancing communication between patients and healthcare providers; and (2) the importance of using simple technology so that a greater number of patients with varying degrees of comfort and capabilities would be able to use the system confidently. A corresponding set of proposed design specifications was devised. CONCLUSIONS: The results of this study provide actionable ways to operationalize patient-centered ideas in the design of an automated preprocedure fasting instruction system.

Every Second Patient Does Not Fully Understand Written Preprocedure Information: An Explorative Study About Functional Health Literacy.

PURPOSE: To investigate the self-perceived functional health literacy (FHL) of patients who underwent advanced endoscopic treatment, explore whether FHL could explain aspects of patients' perioperative experiences, and determine whether patients read the provided patient information. DESIGN: A prospective cross-sectional explorative study. METHODS: One hundred patients who underwent endoscopic bile duct intervention were enrolled and asked to answer the Swedish version of the FHL Scale and their perioperative experiences of the intervention. Along with procedural data, all data were analyzed for group comparisons; high or low FHL. FINDINGS: The study included a total of 100 patients, with half of them rating their FHL as problematic or inadequate (low FHL). Among those who perceived their FHL as inadequate, a majority had not read the provided information before the procedure. Patients with problematic or inadequate FHL experienced perioperative anxiety and pain more frequently than those with sufficient FHL (high FHL). CONCLUSIONS: This study supports previous research on the association between low FHL and patients' well-being. To better meet patients' information needs, it is crucial for nurse anesthetists and other health care providers to have knowledge about FHL. Additionally, the study highlights the importance of using alternative and more effective means of delivering information to patients.

Procedural sedation for paediatric patients with spinal muscular atrophy undergoing intrathecal treatment.

AIMS: Nusinersen is administered intrathecally for treating spinal muscular atrophy (SMA). Procedural sedation is common with intrathecal treatment in children. The purpose of this study is to emphasize that intrathecal treatment of paediatric patients with SMA I, II and III can be tolerated with procedural sedation instead of general anaesthesia. METHODS: Data were collected the from the anaesthesia charts and electronic medical records of 14 paediatric patients with SMA types I, II and III who underwent procedural sedation for repeated intrathecal treatments for SMA. Intravenous induction was performed, and patients were oxygenated with a face mask or nasal cannula while spontaneous breathing continued. RESULTS: Fourteen patients were included in the study: one SMA I, eight SMA II and five SMA III. They underwent 88 intrathecal nusinersen injections in total. In the one SMA I patient, of 8 months, the procedure was performed under local anaesthesia. In all other patients, the treatments were performed under procedural sedation. Different combinations of midazolam, ketamine, propofol, fentanyl and remifentanil were used. The mean doses of the agents used were 0.03 mg kg-1 , 0.97 mg kg-1 , 2.71 mg kg-1 , 0.84 µg kg-1 and 0.5 µg kg-1 , respectively. There were no intraoperative or postoperative complications. CONCLUSION: We found the procedural sedation to be sufficient, safe and effective in SMA II and III paediatric patients who underwent nusinersen treatment intrathecally, provided anaesthetic agents are titrated and administered carefully.

Development of a pharmacokinetic and pharmacodynamic model for intranasal administration of midazolam in older adults: a single-site two-period crossover study.

BACKGROUND: Intranasal midazolam can produce procedural sedation in frail older patients with dementia who are unable to tolerate necessary medical or dental procedures during domiciliary medical care. Little is known about the pharmacokinetics and pharmacodynamics of intranasal midazolam in older (>65 yr old) people. The aim of this study was to understand the pharmacokinetic/pharmacodynamic properties of intranasal midazolam in older people with the primary goal of developing a pharmacokinetic/pharmacodynamic model to facilitate safer domiciliary sedation care. METHODS: We recruited 12 volunteers: ASA physical status 1-2, aged 65-80 yr, and received midazolam 5 mg intravenously and 5 mg intranasally on two study days separated by a 6 day washout period. Concentrations of venous midazolam and 1'-OH-midazolam, Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score, bispectral index (BIS), arterial pressure, ECG, and respiratory parameters were measured for 10 h. RESULTS: Time to peak effect of intranasal midazolam for BIS, MAP, and SpO2 were 31.9 (6.2), 41.0 (7.6), and 23.1 (3.0) min, respectively. Intranasal bioavailability was lower compared with intravenous administration (Fabs 95%; 95% confidence interval: 89-100%). A three-compartment model best described midazolam pharmacokinetics following intranasal administration. A separate effect compartment linked to the dose compartment best described an observed time-varying drug-effect difference between intranasal and intravenous midazolam, suggesting direct nose-to-brain transport. CONCLUSIONS: Intranasal bioavailability was high and sedation onset was rapid, with maximum sedative effects after 32 min. We developed a pharmacokinetic/pharmacodynamic model for intranasal midazolam for older persons and an online tool to simulate changes in MOAA/S, BIS, MAP, and SpO2 after single and additional intranasal boluses. CLINICAL TRIAL REGISTRATION: EudraCT (2019-004806-90).

Dexmedetomidine for sedation during hematopoietic stem cell harvest apheresis and leukapheresis in the PICU: Guideline development.

BACKGROUND: Hematopoietic stem cell (HSC) harvest apheresis and leukapheresis are performed in the pediatric intensive care unit (PICU) for high-risk pediatric patients who require procedural sedation. Patients need central access either with their own central lines, ports or require apheresis catheter (CVL) placement. Previously, patients were either awake or emerging from sedation on PICU admission. Uncertainty regarding procedural sedation plans caused delays initiating sedation and apheresis. A guideline was developed to standardize Dexmedetomidine (DEX) for procedural sedation. We investigated if guideline implementation would improve efficiency during PICU admission as demonstrated by shorter time intervals for initiation of sedation, apheresis, PICU length of stay and less alternative sedating medication. METHODS: Data was collected retrospectively from electronic health records of preguideline and post-guideline patients who were admitted to the PICU for sedated apheresis. We compared demographic and clinical characteristics, time intervals for sedation, apheresis, PICU length of stay, and sedation agents between the two groups using Fisher Exact tests and Mann-Whitney tests, as appropriate. RESULTS: The groups did not differ in age or weight at the time of apheresis. All intervals of time compared were shorter post-guideline. Time intervals from admission to start of sedation, admission to start of apheresis, and admission to end of apheresis were statistically significantly different. The type and number of alternative sedating medications administered did not differ between the two groups. CONCLUSION: This guideline implementation improved efficiency during PICU admission. This study might have been too small to demonstrate statistically significant differences in other time intervals studied.

Nurse-driven intranasal dexmedetomidine administration as sedation for non-invasive procedures in children: a single centre audit.

The purpose of this study is to audit the efficacy and safety of intranasal dexmedetomidine sedation for non-invasive procedural sedation in children provided by nurses of the procedural sedation (PROSA) team in the University Hospitals Leuven. Efficacy (successful sedation as sole sedative) and safety (cardiorespiratory monitoring, saturation) were assessed. In this audit, prospectively recorded data were extracted from the medical files in 772 patients between 4 weeks to 18 years old, who underwent sedation with intranasal dexmedetomidine (2-4 µg/kg) by the nurse-driven PROSA team, following pre-screening on risk factors. Ninety-one percent of the patients were successfully sedated (single dose, monotherapy), 60 patients (7.8%) needed an additional intervention during sedation, 37 (4.8%) needed an extra dose of intranasal dexmedetomidine, and 14 (1.8%) received an additional other sedative. Successful sedation rates were higher in younger children, and medical imaging was the most common indication. Sedation failed in 12 (1.6%) patients, with 10 of them failed to fall asleep. Adverse events were limited in number (n = 13, 1.7%) and severity: 4 patients had a low heart rate (one received atropine), one had an irregular heart rate, and 7 desaturation events were described. Hypotension was treated with normal saline in one case. CONCLUSIONS: In this nurse-driven PROSA setting, intranasal dexmedetomidine is effective and safe for non-invasive procedural sedation in an a priori low risk group of paediatric patients. WHAT IS KNOWN: • Procedural sedation outside the operating theatre or intensive care units is increasingly used, including sedation performed by non-anaesthesiologists or nurses. This resulted in the development of procedural sedation and analgesia (PROSA) teams. • Off-label use of intranasal dexmedetomidine in children is increasing, with a limited number of audits on this practice, its safety and efficacy. WHAT IS NEW: • In an audit on 772 procedures, nurse-driven intranasal dexmedetomidine administration as sedation for non-invasive procedures in children within a structured framework was safe and effective. • Imaging (CT, MRI) was the most common procedural indication in our study, but also nuclear imaging techniques were included.

Effect of high-flow nasal oxygen on hypoxaemia during procedural sedation: a systematic review and meta-analysis.

We conducted a systematic review to evaluate the effect of high-flow nasal oxygen and conventional oxygen therapy during procedural sedation amongst adults and children. We searched MEDLINE, EMBASE and CINAHL for randomised controlled trials that reported the effects of high-flow nasal oxygen during procedural sedation. The primary outcome measure was hypoxaemia and the secondary outcomes were minimum oxygen saturation; hypercarbia; requirement for airway manoeuvres; and procedure interruptions. The quality of evidence was assessed using the revised Cochrane risk-of bias tool and grading of recommendations, assessment, development and evaluation (GRADE). Nineteen randomised controlled trials (4121 patients) including three in children were included. Administration of high-flow nasal oxygen reduced hypoxaemia, risk ratio (95%CI) 0.37 (0.24-0.56), p < 0.001; minor airway manoeuvre requirements, risk ratio (95%CI) 0.26 (0.11-0.59), p < 0.001; procedural interruptions, risk ratio (95%CI) 0.17 (0.05-0.53), p = 0.002; and increased minimum oxygen saturation, mean difference (95%CI) 4.1 (2.70-5.50), p < 0.001; as compared with the control group. High-flow nasal oxygen had no impact on hypercarbia, risk ratio (95%CI) 1.24 (0.97-1.58), p = 0.09, I2 = 0%. High-flow nasal oxygen reduced the incidence of hypoxaemia regardless of the procedure involved, degree of fractional inspired oxygen, risk-profile of patients and mode of propofol administration. The evidence was ascertained as moderate for all outcomes except for procedure interruptions. In summary, high-flow nasal oxygen compared with conventional oxygenation techniques reduced the risk of hypoxaemia, increased minimum oxygen saturation and reduced the requirement for airway manoeuvres. High-flow nasal oxygen should be considered in patients at risk of hypoxaemia during procedural sedation.

Acupuncture is a feasible alternative to procedural sedation for shoulder reduction in the emergency department.

Treating shoulder dislocations is common in the emergency department and often requires procedural sedation. The use of acupuncture for treatment of chronic pain has been shown to be successful in various outpatient settings, and some EDs have recently incorporated acupuncture as an analgesia adjunct for chronic painful conditions to avoid opioid therapy. Limited data describe acupuncture to facilitate ED procedures. Here we present two cases of acute shoulder dislocation that were successfully treated with acupuncture as an alternative to parenteral pharmacologic procedural sedation. A 50 year old male sustained an anterior shoulder dislocation after an altercation, and a 59 year old female sustained an anterior dislocation after a fall. Instead of using conventional pharmacologic sedation and analgesia during shoulder reduction, both were treated with acupuncture in the ED. Reduction in both cases was rapid, safe, and avoided use of any parenteral medications, procedural sedation monitoring, or prolonged nurse observation. Using acupuncture as alternative to opioids for ED procedures deserves future study for orthopedic and other common ED procedures.