Background: The incidence of sedation-related adverse events, inclusive of both adults and children, administered by multiple specialty providers from different countries and venues, using standardized definitions, has never been reported on an international level. We are reporting the outcome data of the adverse event sedation reporting tool as an important step toward a more complete risk assessment of sedation-related morbidity, mortality, and etiology. The analysis of the AE sedation reporting data include descriptive measures to evaluate the characteristics of the provider, the patient, sedations performed, adverse events, interventions, and outcomes. The primary outcome was the rate and nature of adverse events. Between 12/14/2010 and 12/11/2018 there were 7952 sedations, from an estimated total of 164,114 sedations administered, of which 622 were reported as adverse events. The mean age of the entire patient population is 33.0 years (0.02–98.7). The providers represented 39 countries across six continents. Oxygen desaturation (75%–90%) for <60 s is the most prevalent adverse event with a rate of 7.8 per 10,000, followed by airway obstruction at a rate of 5.42 per 10,000. Apnea occurred at a rate of 4.75 per 10,000. Significant predictors of adverse events are ≥ ASA score III (p = 0.0003), procedure time (6:00 pm–12:00 am: p < 0.0001, 12:00–6:00 am: p = 0.0003), and non-hospital location (p < 0.0001). The AE sedation reporting tool has demonstrated that the majority of adverse events in children and adults who receive procedural sedation from multi-specialists internationally required minor interventions and had outcomes of minor risk.

Remimazolam, an ultra-short-acting benzodiazepine sedative, was first approved in 2020 in Japan as a general anesthetic for adults. However, its utilization in pediatric settings remains unexplored and, to date, is confined to isolated case reports due to a lack of specific pediatric labeling. The primary objective of our study was to evaluate the safety profile of remimazolam when used for procedural sedation in children following dosages established in adult protocols. Additional parameters, including dosage per kg of body weight, duration of the procedure, efficacy (measured as successful completion of the procedure), the necessity for supplemental medications, and changes in physiological parameters, such as the heart rate (HR) and mean arterial blood pressure (MAP), were assessed. Our study encompassed 48 children with an average age of 7.0 years. The objective Tracking and Reporting Outcomes of Procedural Sedation tool indicated no adverse events. In our cohort, propofol and ketamine were used as adjunctive treatments in 8 and 39 patients, respectively, with successful completion of all procedures. Notable hemodynamic variability was observed, with 88.4% of patients experiencing a ≥20% change (increase or decrease) and 62.8% experiencing a ≥30% change in MAP. Additionally, a ≥20% change in HR was observed in 54.3% of patients, and a ≥30% change was observed in 34.8% of patients. Nevertheless, none of the patients required pharmacological intervention to manage these hemodynamic fluctuations. Our findings suggest that remimazolam, when supplemented with propofol or ketamine, could offer a safe and effective pathway for administering procedural sedation in pediatric populations.

Remimazolam was first approved in 2020 as a general anesthetic for adults and still does not have pediatric labeling. Our study will be the first pilot program that administers remimazolam as an adjunct to a general endotracheal anesthetic in children. Between August 2020 and December 2022, electronic medical records were collected for all children who received remimazolam during anesthesia. The remimazolam dosing regimen was extrapolated from the adult package insert, with intravenous induction doses of 12 mg/kg/h administered until the desired effect was achieved. Subsequent infusions were given at a rate of 1–2 mg/kg/h, accompanied by intermittent boluses of 0.2 mg/kg, with all dosing adjustments made according to the anesthesiologist’s clinical discretion. A total of 418 children (mean 4.6 yrs, 68.7% ASA 1 and 2) underwent surgeries which averaged 81.2 min. A total of 75.2% of patients had greater than a 20% change (increase or decrease) in MAP (lowest or highest) from baseline, and 203 (49.3%) patients had greater than a 30% change (increase or decrease) in MAP (lowest or highest) from baseline. A total of 5% received ephedrine to treat unanticipated hemodynamic variability. Discharge criteria were met within an average of 13.8 min after arrival at the post-anesthesia care unit. Remimazolam may offer the benefits of rapid recovery following general endotracheal anesthesia. The risk of hemodynamic variability which necessitates and responds to ephedrine should be anticipated.

The exposure of infants and children to volatile anesthetics, such as sevoflurane, has been a topic of concern with respect to the potential risk for long term neurocognitive effects. The primary objective of this study was to determine whether the perioperative utilization of Bispectral Index (BIS) monitoring alters the sevoflurane delivery and exposure to children. This is a prospective randomized trial of two groups of healthy ambulatory day surgery patients (2 to 12 years). The patients in both groups had the BIS applied soon after the induction of general anesthesia, but only the anesthesiologists in the group randomized to BIS visible were able to see the BIS values. All of the patients received general anesthesia with sevoflurane. This study found no difference in the overall exposure to sevoflurane between both groups (mean end-tidal sevoflurane level of 1.8 in both groups, P = 084). The duration of time in the recovery room, the time to meet discharge criteria, the Pediatric Agitation Emergence Delirium (PAED) scores and the Face, Legs, Activity, Cry, Consolability (FLACC) scores were not statistically different between the groups. The application and utilization of intraoperative BIS monitoring does not alter the sevoflurane administration nor the discharge readiness nor the recovery profile in healthy ambulatory children.

In recent years, remimazolam has gained approval for use in adult procedural sedation in both the United Kingdom and the United States, potentially offering an alternative to conventional sedatives like propofol and midazolam for procedural sedation. However, there is a limited body of literature that systematically reviews the outcomes of a remimazolam-alfentanil combination protocol for routine office-based dental procedures. The primary objective of this pilot study was to assess the occurrence of significant adverse events associated with the use of a remimazolam-alfentanil sedation protocol for adult dental procedures. Secondary outcomes included evaluating physiological responses, sedation effectiveness, patient and clinician satisfaction and the incidence of intraprocedural awareness. Notably, no significant adverse events were reported among the 25 adult subjects who received remimazolam and alfentanil, and all dental procedures were successfully completed. Patients and clinicians expressed high levels of satisfaction, and patients did not report any distressing memories associated with the dental procedure. These findings suggest that in a limited cohort, the remimazolam-alfentanil regimen appears to be well tolerated and effective for office-based dental procedures in adult patients, with a low risk of adverse events, acceptable hemodynamic effects, rapid onset and recovery and minimal intraoperative awareness. This study provides valuable insights into the potential use of the remimazolam-alfentanil combination in dental sedation practice.

Anorectal manometry is one of the most frequently performed gastrointestinal motility studies in children. It is an important study in diagnosing Hirschsprung disease (HD). These procedures can be uncomfortable, painful and emotionally distressing. Nitrous oxide or midazolam are the only pharmacologic options available, as clinical experience suggests that they do not alter manometry readings. Our study was designed to determine whether Dexmedetomidine (DEX) could provide adequate sedation without disrupting anal and rectal pressure. The effect of DEX on anorectal function has never been studied in children. This prospective study recorded anorectal manometry (ARM) measurements prior to the administration of DEX and then repeated the measurements at 1 and 5 min after DEX. The main ARM measurements included resting intra-anal sphincter pressure (IASP) and the presence and characteristics of the recto-anal inhibitory reflex (RAIR). DEX was administered as a bolus followed by a continuous infusion. Twenty patients were included (60% female; mean age 10.8 ± 4.6 years). The RAIR became absent in 2/16 (12.5%) patients after DEX administration. DEX may alter physiologic ARM and IASP recordings necessary to diagnose gastrointestinal medical conditions.