Use of high-flow nasal cannula versus other noninvasive ventilation techniques or conventional oxygen therapy for respiratory support following pediatric cardiac surgery: A systematic review and meta-analysis.

INTRODUCTION: Noninvasive respiratory support may be provided to decrease the risk of postextubation failure following surgery. Despite these efforts, approximately 3%-27% of infants and children still experience respiratory failure after tracheal extubation following cardiac surgery. This systematic review evaluates studies comparing the efficacy of high-flow nasal cannula to conventional oxygen therapy such as nasal cannula and other noninvasive ventilation techniques in preventing postextubation failure in this patient population. METHODS: A systematic and comprehensive search was conducted in major databases including MEDLINE, EMBASE, Web of Science, and Central. The search encompassed articles focusing on the prophylactic use of high-flow nasal cannula following tracheal extubation in pediatric patients undergoing cardiac surgery for congenital heart disease. The inclusion criteria for this review consisted of randomized clinical trials as well as observational, cohort, and case-control studies. RESULTS: A total of 1295 studies were screened and 12 studies met the inclusion criteria. These 12 studies included a total of 1565 children, classified into three groups: seven studies compared high-flow nasal cannula to noninvasive ventilation techniques, four studies compared high-flow nasal cannula to conventional oxygen therapy, and one observational single-arm study explored the use of high-flow nasal cannula with no control group. There was no significant difference in the incidence of tracheal reintubation between high-flow nasal cannula and conventional oxygen therapy (risk ratio [RR] = 0.67, 95% confidence interval [CI]: 0.24-1.90, p = .46). However, there was a lower incidence of tracheal reintubation in patients who were extubated to high-flow nasal cannula versus those extubated to noninvasive ventilation techniques (RR = 0.45, 95% CI: 0.32-0.63, p < .01). The high-flow nasal cannula group also demonstrated a lower mortality rate compared to the noninvasive ventilation techniques group (RR = 0.31, 95% CI: 0.16-0.61, p < .01) as well as a shorter postoperative length of stay (mean difference = -8.76 days, 95% CI: -13.08 to -4.45, p < .01) and shorter intensive care length of stay (mean difference = -4.63 days, 95% CI: -9.16 to -0.11, p = .04). CONCLUSION: High-flow nasal cannula is more effective in reducing the rate of postextubation failure compared to other forms of noninvasive ventilation techniques following surgery for congenital heart disease in pediatric-aged patients. high-flow nasal cannula is also associated with lower mortality rates and shorter length of stay. However, when comparing high-flow nasal cannula to conventional oxygen therapy, the findings were inconclusive primarily due to a limited number of scientific studies available on this specific comparison. Future study is needed to further define the benefit of high-flow nasal cannula compared to conventional oxygen therapy and various types of noninvasive ventilation techniques.

Application of behavioral economic strategies to enhance recruitment into a pediatric randomized clinical trial for postoperative pain relief: A randomized clinical trial.

INTRODUCTION: A major challenge in conducting clinical trials is recruitment. Trial under-enrollment leads to underpowered studies. Behavioral economics offers strategies that may enhance trial recruitment. This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial assessing a biofeedback-based virtual reality intervention for postoperative pain management. We hypothesized the behavioral economics-informed approach would increase enrollment into the future trial, intention to adhere to therapy, acceptability of the intervention, and perceived efficacy while decreasing perception of treatment burden and risk. METHODS: This single-center, prospective, randomized trial recruited patients 12-18 years old undergoing surgery requiring postoperative admission and narcotic administration. Patient-parent dyads were randomized to watch a behavioral economics-informed (n = 64) or standard biological (n = 66) recruitment video about a study designed to assess impact of a virtual reality pain management intervention. RESULTS: There was no difference in rates of intention to enroll in the study between groups (behavioral economics: 75%, control: 79%, p = 0.744) or in median response scores to questions regarding intention to adhere to therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.084), acceptability of therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p = 0.376), perceptions of treatment burden (3.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.251), and efficacy (3.0 [3.0, 4.0] vs. 3.0 [3.0, 4.0], p = 0.914). Patients in the behavioral economics group were less likely to perceive risk associated with virtual reality versus the control group (behavioral economics: 2.0 [1.0, 2.0], control: 2.0 [2.0, 3.0], p = 0.023). DISCUSSION: A behavioral economics-informed video did not increase patients' intentions to enroll into a clinical trial assessing the impact of virtual reality intervention for postoperative pain management. CONCLUSION: Either approach would be sufficient for patient recruitment for this type of clinical trial since the overall intention to enroll rate was 77%.

The role of local inflammation in complications associated with intubation in pediatric patients: A narrative review.

Although the most important primary local inflammatory response factor to intubation is not yet clear, it is known that it may be directly attributed to the presence of trauma during intubation or the response of oral bacterial flora present in the trachea. It is known that prolonged intubation is associated with worse outcomes, but other underlying systemic issues, such as sepsis and trauma, are also associated with this result. Likewise, patients who require advanced airway management and excessive manipulation are more likely to experience complications. There are various inflammatory mediators that are generated during orotracheal intubation, many of which can be considered targets for therapies to help reduce inflammation caused by intubation. However, there is little evidence on the management of the inflammatory response induced by orotracheal intubation in pediatric patients. Therefore, the aim of this narrative review is to highlight the intubation associated complications that can arise from poorly controlled inflammation in intubated pediatric patients, review the proposed pathophysiology behind this, and discuss the current treatments that exist. Finally, taking into account the discussion on pathophysiology, we describe the current therapies being developed and future directions that can be taken in order to create more treatment options within this patient population.

Beyond mortality: definitions and benchmarks of outcome standards in paediatric anaesthesiology.

PURPOSE OF REVIEW: The aim of this study was to review the evolution of safety and outcomes in paediatric anaesthesia, identify gaps in quality and how these gaps may influence outcomes, and to propose a plan to address these challenges through the creation of universal outcome standards and a paediatric anaesthesia designation programme. RECENT FINDINGS: Tremendous advancements in the quality and safety of paediatric anaesthesia care have occurred since the 1950 s, resulting in a near absence of documented mortality in children undergoing general anaesthesia. However, the majority of data we have on paediatric anaesthesia outcomes come from specialized academic institutions, whereas most children are being anaesthetized outside of free-standing children's hospitals. SUMMARY: Although the literature supports dramatic improvements in patient safety during anaesthesia, there are still gaps, particularly in where a child receives anaesthesia care and in quality outcomes beyond mortality. Our goal is to increase equity in care, create standardized outcome measures in paediatric anaesthesia and build a verification system to ensure that these targets are accomplished. The time has come to benchmark paediatric anaesthesia care and increase quality received by all children with universal measures that go beyond simply mortality.

Paediatric pain management: from regional to virtual.

PURPOSE OF REVIEW: Due to increased interest in opioid-sparing multimodal analgesic strategies both inside and outside of the operating room, anaesthesiologists have started to look towards regional anaesthesia as well as nonpharmacological pain-reducing techniques. The purpose of this article is to discuss current trends and recent developments in regional anaesthesia and virtual reality for paediatric pain management. RECENT FINDINGS: The development of novel fascial plane blocks has expanded regional options for anaesthesiologists, especially when neuraxial anaesthesia is not a viable or straightforward option. Other regional techniques, such as spinal anaesthesia and continuous epidural analgesia for infants and neonates, are becoming more popular, as more paediatric anaesthesiologists become familiar with these techniques. Virtual reality for paediatric pain management is a relatively new area of study that has shown promise, but more research needs to be done before widespread adoption of this practice becomes a reality. Various preexisting pain-reducing strategies such as distraction and biofeedback are being integrated with virtual reality to help optimize its effect on pain and anxiety for paediatric patients. SUMMARY: Regional anaesthesia and virtual reality are valuable tools that serve to alleviate pain in paediatric patients. Advances are being made within both fields in various healthcare settings for different types of pain. Over the next few years, they will likely both play an increasing role in paediatric pain management.

Isoelectric Electroencephalography in Infants and Toddlers during Anesthesia for Surgery: An International Observational Study.

BACKGROUND: Intraoperative isoelectric electroencephalography (EEG) has been associated with hypotension and postoperative delirium in adults. This international prospective observational study sought to determine the prevalence of isoelectric EEG in young children during anesthesia. The authors hypothesized that the prevalence of isoelectric events would be common worldwide and associated with certain anesthetic practices and intraoperative hypotension. METHODS: Fifteen hospitals enrolled patients age 36 months or younger for surgery using sevoflurane or propofol anesthetic. Frontal four-channel EEG was recorded for isoelectric events. Demographics, anesthetic, emergence behavior, and Pediatric Quality of Life variables were analyzed for association with isoelectric events. RESULTS: Isoelectric events occurred in 32% (206 of 648) of patients, varied significantly among sites (9 to 88%), and were most prevalent during pre-incision (117 of 628; 19%) and surgical maintenance (117 of 643; 18%). Isoelectric events were more likely with infants younger than 3 months (odds ratio, 4.4; 95% CI, 2.57 to 7.4; P < 0.001), endotracheal tube use (odds ratio, 1.78; 95% CI, 1.16 to 2.73; P = 0.008), and propofol bolus for airway placement after sevoflurane induction (odds ratio, 2.92; 95% CI, 1.78 to 4.8; P < 0.001), and less likely with use of muscle relaxant for intubation (odds ratio, 0.67; 95% CI, 0.46 to 0.99; P = 0.046]. Expired sevoflurane was higher in patients with isoelectric events during preincision (mean difference, 0.2%; 95% CI, 0.1 to 0.4; P = 0.005) and surgical maintenance (mean difference, 0.2%; 95% CI, 0.1 to 0.3; P = 0.002). Isoelectric events were associated with moderate (8 of 12, 67%) and severe hypotension (11 of 18, 61%) during preincision (odds ratio, 4.6; 95% CI, 1.30 to 16.1; P = 0.018) (odds ratio, 3.54; 95% CI, 1.27 to 9.9; P = 0.015) and surgical maintenance (odds ratio, 3.64; 95% CI, 1.71 to 7.8; P = 0.001) (odds ratio, 7.1; 95% CI, 1.78 to 28.1; P = 0.005), and lower Pediatric Quality of Life scores at baseline in patients 0 to 12 months (median of differences, -3.5; 95% CI, -6.2 to -0.7; P = 0.008) and 25 to 36 months (median of differences, -6.3; 95% CI, -10.4 to -2.1; P = 0.003) and 30-day follow-up in 0 to 12 months (median of differences, -2.8; 95% CI, -4.9 to 0; P = 0.036). Isoelectric events were not associated with emergence behavior or anesthetic (sevoflurane vs. propofol). CONCLUSIONS: Isoelectric events were common worldwide in young children during anesthesia and associated with age, specific anesthetic practices, and intraoperative hypotension.

Role of sugammadex in the treatment of anaphylaxis due to rocuronium in children: Extrapolation from adult and animal reports.

Allergic reactions are generalized hypersensitivity processes triggered by different antigenic stimuli, resulting in the end effect of mast cell degranulation and adverse physiologic effects. During the perioperative period, the most commonly identified agents include antibiotics, neuromuscular blocking agents (rocuronium and succinylcholine), chlorhexidine, and iodinated dyes for radiologic imaging. Sugammadex is a novel agent for the reversal of neuromuscular blockade achieved with rocuronium or vecuronium. Its unique mechanism of action, whereby it encapsulates and forms a one-to-one complex with rocuronium, has led to its anecdotal use as an adjunct in the treatment of anaphylactic and anaphylactoid reactions following rocuronium. The current manuscript discusses the potential use of sugammadex in the treatment of allergic reactions following the administration of rocuronium, reviews previous anecdotal reports of its use in these scenarios, and provides recommendations for future care.

Setting a universal standard: Should we benchmark quality outcomes for pediatric anesthesia care?

Anesthesiology is a medical specialty well known for its work in patient safety, allowing the field to show a dramatic decrease in perioperative morbidity and mortality in both adults and children since the 1950s. Currently, anesthesia-related mortality is close to zero in healthy children, with deaths occurring primarily in children ASA physical status ≥4. Survival during anesthesia today represents the expectation and standard of care, rather than a marker of quality. Several programs and organizations have created measures to assess safety in pediatric anesthesia-yet none are universally accepted as safety metrics or bundled to evaluate specific aspects of care. In addition, collection of this nonstandardized data in individual centers requires a significant investment of resources and personnel limiting access to only large, "resource-rich" institutions. In this perspective paper, we provide an overview of the efforts made to enhance quality of care across medical specialties with a specific emphasis on pediatric anesthesiology. We discuss the need for standardization of metrics to establish targets and benchmarks for the delivery of high-quality care to children and adolescents mainly in North America. The time has come to move beyond mortality and establish universally accepted minimum outcome standards in pediatric anesthesia. We believe this will ultimately improve confidence in the quality of pediatric anesthesia care offered to children, no matter where they are receiving that care.

Transient Reductions in Postoperative Pain and Anxiety with the Use of Virtual Reality in Children.

OBJECTIVE: Virtual reality is a promising method to manage pain. Distraction-based virtual reality (VR-D) is thought to reduce pain by redirecting attention. Although VR-D can reduce pain associated with acutely painful procedures, it is unclear whether VR-D can reduce pain after surgery. We assessed the ability of a single VR-D session to decrease postoperative pain and anxiety and explored whether pain catastrophizing and anxiety sensitivity influenced these outcomes in children after surgery. DESIGN: Single-center, prospective, pilot study. SETTING: Cincinnati Children's Hospital Medical Center (CCHMC). SUBJECTS: Fifty children (7-21 years of age) with postoperative pain followed by the Acute Pain Service. METHODS: Patients received one VR-D session after surgery. Before the session, patients completed pain catastrophizing (Pain Catastrophizing Scale for Children) and anxiety sensitivity (Child Anxiety Sensitivity Index) questionnaires. The primary outcome consisted of changes in pain intensity after VR-D (immediately, 15 minutes, and 30 minutes). Secondary outcomes included changes in pain unpleasantness and anxiety. RESULTS: VR-D use was associated with a decrease in pain intensity immediately and 15 minutes after VR-D. Reductions in pain unpleasantness were observed up to 30 minutes after VR-D. VR-D was also associated with a reduction in anxiety immediately and at 15 minutes. Although patients with higher pain catastrophizing had higher baseline pain intensity and unpleasantness, they did not show larger pain reductions after VR-D than those with lower pain catastrophizing. CONCLUSIONS: VR-D may be beneficial in transiently reducing pain intensity, unpleasantness, and anxiety in children with postoperative pain. This study informs the design of a larger, randomized, controlled study assessing VR-D for acute postoperative pain and anxiety management.

Guided Relaxation-Based Virtual Reality for Acute Postoperative Pain and Anxiety in a Pediatric Population: Pilot Observational Study.

BACKGROUND: Distraction-based therapies, such as virtual reality (VR), have been used to reduce pain during acutely painful procedures. However, distraction alone cannot produce prolonged pain reduction to manage sustained postoperative pain. Therefore, the integration of VR with other pain-reducing therapies, like guided relaxation, may enhance its clinical impact. OBJECTIVE: The goal of this pilot study was to assess the impact of a single guided relaxation-based VR (VR-GR) session on postoperative pain and anxiety reduction in children. We also explored the influence of pain catastrophizing and anxiety sensitivity on this association. METHODS: A total of 51 children and adolescents (7-21 years) with postoperative pain and followed by the Acute Pain Service at Cincinnati Children's Hospital were recruited over an 8-month period to undergo a single VR-GR session. Prior to VR, the patients completed 2 questionnaires: Pain Catastrophizing Scale for Children (PCS-C) and the Child Anxiety Sensitivity Index (CASI). The primary outcome was a change in pain intensity following the VR-GR session (immediately, 15 minutes, and 30 minutes). The secondary outcomes included changes in pain unpleasantness and anxiety. RESULTS: The VR-GR decreased pain intensity immediately (P<.001) and at 30 minutes (P=.04) after the VR session, but not at 15 minutes (P=.16) postsession. Reductions in pain unpleasantness were observed at all time intervals (P<.001 at all intervals). Anxiety was reduced immediately (P=.02) but not at 15 minutes (P=.08) or 30 minutes (P=.30) following VR-GR. Patients with higher CASI scores reported greater reductions in pain intensity (P=.04) and unpleasantness (P=.01) following VR-GR. Pain catastrophizing was not associated with changes in pain and anxiety. CONCLUSIONS: A single, short VR-GR session showed transient reductions in pain intensity, pain unpleasantness, and anxiety in children and adolescents with acute postoperative pain. The results call for a future randomized controlled trial to assess the efficacy of VR-GR. TRIAL REGISTRATION: ClinicalTrials.gov NCT04556747; https://clinicaltrials.gov/ct2/show/NCT04556747.

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management.

BACKGROUND: Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. OBJECTIVE: The INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. METHODS: An interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. RESULTS: Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. CONCLUSIONS: To realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children.

Statistical Analysis Plan for "An international multicenter study of isoelectric electroencephalography events in infants and young children during anesthesia for surgery".

This Statistical Analysis Plan details the statistical procedures to be applied for the analysis of data for the multicenter electroencephalography study. It consists of a basic description of the study in broad terms and separate sections that detail the methods of different aspects of the statistical analysis, summarized under the following headings (a) Background; (b) Definitions of protocol violations; (c) Definitions of objectives and other terms; (d) Variables for analyses; (e) Handling of missing data and study bias; (f) Statistical analysis of the primary and secondary study outcomes; (g) Reporting of study results; and (h) References. It serves as a template for researchers interested in writing a Statistical Analysis Plan.

An International, Multicenter, Observational Study of Cerebral Oxygenation during Infant and Neonatal Anesthesia.

BACKGROUND: General anesthesia during infancy is associated with neurocognitive abnormalities. Potential mechanisms include anesthetic neurotoxicity, surgical disease, and cerebral hypoxia-ischemia. This study aimed to determine the incidence of low cerebral oxygenation and associated factors during general anesthesia in infants. METHODS: This multicenter study enrolled 453 infants aged less than 6 months having general anesthesia for 30 min or more. Regional cerebral oxygenation was measured by near-infrared spectroscopy. We defined events (more than 3 min) for low cerebral oxygenation as mild (60 to 69% or 11 to 20% below baseline), moderate (50 to 59% or 21 to 30% below baseline), or severe (less than 50% or more than 30% below baseline); for low mean arterial pressure as mild (36 to 45 mmHg), moderate (26 to 35 mmHg), or severe (less than 25 mmHg); and low pulse oximetry saturation as mild (80 to 89%), moderate (70 to 79%), or severe (less than 70%). RESULTS: The incidences of mild, moderate, and severe low cerebral oxygenation were 43%, 11%, and 2%, respectively; mild, moderate, and severe low mean arterial pressure were 62%, 36%, and 13%, respectively; and mild, moderate, and severe low arterial saturation were 15%, 4%, and 2%, respectively. Severe low oxygen saturation measured by pulse oximetry was associated with mild and moderate cerebral desaturation; American Society of Anesthesiology Physical Status III or IV versus I was associated with moderate cerebral desaturation. Severe low cerebral saturation events were too infrequent to analyze. CONCLUSIONS: Mild and moderate low cerebral saturation occurred frequently, whereas severe low cerebral saturation was uncommon. Low mean arterial pressure was common and not well associated with low cerebral saturation. Unrecognized severe desaturation lasting 3 min or longer in infants seems unlikely to explain the subsequent development of neurocognitive abnormalities.

Characterization of the functional near-infrared spectroscopy response to nociception in a pediatric population.

BACKGROUND: Near-infrared spectroscopy can interrogate functional optical signal changes in regional brain oxygenation and blood volume to nociception analogous to functional magnetic resonance imaging. AIMS: This exploratory study aimed to characterize the near-infrared spectroscopy signals for oxy-, deoxy-, and total hemoglobin from the brain in response to nociceptive stimulation of varying intensity and duration, and after analgesic and neuromuscular paralytic in a pediatric population. METHODS: We enrolled children 6 months-21 years during propofol sedation before surgery. The near-infrared spectroscopy sensor was placed on the forehead and nociception was produced from an electrical current applied to the wrist. We determined the near-infrared spectroscopy signal response to increasing current intensity and duration, and after fentanyl, sevoflurane, and neuromuscular paralytic. Heart rate and arm movement during electrical stimulation was also recorded. The near-infrared spectroscopy signals for oxy-, deoxy-, and total hemoglobin were calculated as optical density*time (area under curve). RESULTS: During electrical stimulation, nociception was evident: tachycardia and arm withdrawal was observed that disappeared after fentanyl and sevoflurane, whereas after paralytic, tachycardia persisted while arm withdrawal disappeared. The near-infrared spectroscopy signals for oxy-, deoxy-, and total hemoglobin increased during stimulation and decreased after stimulation; the areas under the curves were greater for stimulations 30 mA vs 15 mA (13.9 [5.6-22.2], P = .0021; 5.6 [0.8-10.5], P = .0254, and 19.8 [10.5-29.1], P = .0002 for HbO2 , Hb, and HbT , respectively), 50 Hz vs 1 Hz (17.2 [5.8-28.6], P = .0046; 7.5 [0.7-14.3], P = .0314, and 21.9 [4.2-39.6], P = .0177 for HbO2 , Hb, and HbT , respectively) and 45 seconds vs 15 seconds (16.3 [3.4-29.2], P = .0188 and 22.0 [7.5-36.5], P = .0075 for HbO2 and HbT , respectively); the areas under the curves were attenuated by analgesics but not by paralytic. CONCLUSION: Near-infrared spectroscopy detected functional activation to nociception in a broad pediatric population. The near-infrared spectroscopy response appears to represent nociceptive processing because the signals increased with noxious stimulus intensity and duration, and were blocked by analgesics but not paralytics.

Opioid-related adverse effects in children undergoing surgery: unequal burden on younger girls with higher doses of opioids.

OBJECTIVE: Unpredictable interindividual variability in response to opioids results in inadequate analgesia and opioid-related adverse effects. The effects of the child's sex on opioid response have not been well studied. The aim of this study is to determine the effects of sex on opioid-related adverse effects in children undergoing tonsillectomy. DESIGN: Prospective observational clinical study. SETTING: Outpatient pediatric surgery. SUBJECTS: Two hundred and seventy five children between 6 and 15 years of age undergoing outpatient tonsillectomy. METHODS: All children received standard perioperative care with a standard intraoperative dose of morphine. Opioid-related analgesia and safety outcomes included incidences of respiratory depression (RD), postoperative nausea and vomiting (PONV) and incidence of prolonged stay in the, post-anesthesia recovery unit (PACU) due to opioid related adverse effects. RESULTS: Given the small sample of minority population, we focused our study on 219 white children. Significant morphine effect was observed in girls but not boys for PONV (P = 0.001) and prolonged PACU stay due to PONV (P = 0.010). Although the overall incidence of RD is not statistically different between boys and girls, the incidence of RD (52% vs 32%) and PONV (43% vs 4%) tended to be more in white girls than boys as the total perioperative morphine dose increased to 0.3 mg/kg or more. CONCLUSIONS: This study demonstrates that child's sex influences morphine's dose response and adverse effects. White girls have an unequal burden with higher incidences of PONV, RD, and prolonged PACU stays following tonsillectomy from PONV and RD as total morphine doses are increased.

Feasibility and Acceptability of Biofeedback-Based Virtual Reality System Use in Children and Adolescents Undergoing Surgery: Phase 1 of a Pilot Observational Study.

BACKGROUND: Biofeedback-based virtual reality (VR-BF) is a novel, nonpharmacologic method for teaching patients how to control their breathing, which in turn increases heart rate variability (HRV) and may reduce pain. Unlike traditional forms of biofeedback (BF), VR-BF is delivered through a gamified virtual reality environment, increasing the accessibility of BF. This is the first study to systematically integrate VR-BF use in the pediatric perioperative setting, with the ultimate goal of evaluating the efficacy of VR-BF to reduce pain, anxiety, and opioid consumption once feasibility and acceptability has been established. OBJECTIVE: The primary objective was to develop a clinical trial protocol for VR-BF use in the pediatric perioperative setting, including preoperative education/training and postoperative application of VR-BF in children undergoing surgery. A secondary objective was to evaluate the patient/parent experience with VR-BF. METHODS: A total of 23 patients (12-18 years of age) scheduled for surgery at Nationwide Children's Hospital were recruited using purposive sampling. Following training, participants independently completed a daily, 10-minute VR-BF session for seven days before surgery and during their inpatient stay. Participants could use VR-BF up to two weeks after hospital discharge. Patient and session-level data of VR-BF usage and achievement of target HRV parameters were measured to identify the optimal frequency and duration of sessions before and after surgery for this population. Standardized questionnaires and semi-structured interviews were conducted to obtain qualitative information about patients' experiences with VR-BF. RESULTS: Patient-level data indicated that the highest odds of achieving 1 session under target HRV parameters was after 4 sessions (OR 4 vs. 3 sessions=5.1, 95% CI 1.3-20.6; OR 3 vs. 2 sessions=16.6, 95% CI 1.2-217.0). Session-level data showed that a session duration of 9 to 10 minutes provided the greatest odds of achieving 1 session under target HRV parameters (OR 9 vs. 8 minutes=1.3, 95% CI 1.1-1.7; OR 8 vs. 7 minutes=1.4, 95% CI 1.1-1.8; OR 10 vs. 9 minutes=1.0, 95% CI 0.9-1.2). Qualitative data revealed patient satisfaction with the VR-BF technology, particularly in managing perioperative stress (n=17, 85%). Few patients reported VR-BF as beneficial for pain (n=8, 40%). CONCLUSIONS: Children and adolescents undergoing surgery successfully learned behavioral strategies with VR-BF with once-daily 10-minute sessions for 5 days. To integrate VR-BF as a therapeutic intervention in a subsequent clinical trial, patients will be instructed to complete three 10-minute sessions a day for 7 days after surgery. CLINICALTRIAL: ClinicalTrials.gov; NCT04943874; https://clinicaltrials.gov/ct2/show/NCT04943874.