Abstract
-
Purpose
To analyze the general, clinical, and sedation-related characteristics of pediatric inpatients who received procedural sedation from pediatric sedation nurses, and to identify the incidence of sedation-related adverse events and sedation failure.
-
Methods
The medical records of 585 patients under 18 years who were hospitalized in the pediatric wards of a tertiary hospital and received procedural sedation from pediatric sedation nurses from April to September 2023 were retrospectively reviewed. Data were analyzed using chi-square and t-tests.
-
Results
Among the 585 participants, 59.3% were male, and the median age was 38 months. The main departments were hemato-oncology (17.9%), neurology (16.1%), and thoracic surgery (11.8%). A total of 671 procedures were performed; the main ones were echocardiography (18.3%), computed tomography (15.1%), and magnetic resonance imaging (14.0%). 84.6% of the patients experienced no adverse events. The main adverse event was oxygen desaturation (13.2%), with interventions including oxygen supplementation (12.1%) and airway repositioning (4.6%). Adverse events occurred significantly more often in patients in American Society of Anesthesiologists class III–IV (χ2=15.35, p<.001), neurology patients (χ2=7.10, p=.008), patients undergoing spinal tapping (χ2=9.49, p=.002), patients undergoing multiple procedures (χ2=7.64, p=.006), and those receiving combined oral and intravenous sedation (χ2=53.82, p<.001).
-
Conclusion
Procedural sedation provided by pediatric sedation nurses was performed safely and effectively for pediatric inpatients with various characteristics. Further research is necessary to assess pediatric sedation nurses’ current sedation practices across various medical institutions and clinical settings.
-
Key words: Drug-related side effects and adverse reactions; Nurses; Pediatric nursing; Procedural sedation
INTRODUCTION
Pediatric patients are highly vulnerable to anxiety and fear in the unfamiliar hospital environment, which can make it difficult to complete necessary diagnostic or therapeutic procedures [
1]. These medical experiences may intensify procedural distress and precipitate long-term psychological trauma, including an increased fear of hospitalization, highlighting the importance of minimizing pre-procedural anxiety across pediatric care settings [
2]. Procedural sedation is a critical technique that enables safe performance of uncomfortable examinations or procedures while alleviating anxiety and maintaining cardiopulmonary stability [
3]. As diagnostic and therapeutic procedures for children are increasing globally, including in South Korea, the importance of pediatric sedation is being increasingly emphasized [
4,
5].
However, when procedural sedation is performed outside the operating room, limited equipment and staffing can make it hard to respond quickly to emergencies, which may lead to safety problems [
6]. Although the need for dedicated personnel to independently monitor and manage procedural sedation has long been acknowledged, adherence to this standard in South Korea has been challenging owing to a shortage of healthcare professionals [
7]. In 2018, five adverse events related to sedation outside the operating room were reported nationally, including three deaths, one temporary impairment, and one full recovery without sequelae [
8]. To prevent recurrence of such events, the Korea Institute for Healthcare Accreditation recommended assigning a dedicated sedation provider, either a physician or nurse who is not involved in the procedure, to continuously monitor patient status during sedation [
9]. In response, a tertiary hospital in Seoul established a pediatric sedation nurse role in 2019, developing a ward-based sedation protocol to improve safety and quality for hospitalized and outpatient pediatric patients.
Internationally, nurse-administered procedural sedation has been well established as a safe and effective practice, particularly in radiology and outpatient settings [
10-
12]. However, research on structured implementation of nurse-administered sedation in inpatient pediatric settings remains relatively limited, particularly in the context of South Korean hospital settings. Only a few studies in the country have examined pediatric sedation nursing. Kim et al. [
13] in 2021 evaluated nurses’ knowledge and performance related to pediatric sedation and emphasized the need for standardized education and clinical guidelines, while Seo and Park [
14] in 2021 investigated caregivers’ awareness, nursing needs, and satisfaction regarding procedural sedation in hospitalized children. More recently, Park et al. [
15] in 2023 conducted a prospective study investigating the evidence for sleep deprivation as a nonpharmacological nursing intervention prior to chloral hydrate administration in pediatric sedation. Although these studies contributed to understanding specific aspects of sedation care, they mainly focused on knowledge, perceptions, or single procedural factors rather than analyzing actual nursing practices or clinical outcomes related to sedation care. Thus, empirical evidence describing nurse-administered pediatric sedation practices and their implications for patient safety remains insufficient.
Pediatric procedural sedation requires a continuum of coordinated nursing care encompassing pre-sedation assessment, medication administration, continuous physiologic monitoring, and recovery evaluation, as well as appropriate education and guidance for caregivers [
5]. During procedural sedation, pediatric ward nurses face increased workload owing to additional nursing demands from caregivers [
14], and excessive workload in inpatient settings has been associated with adverse events that may compromise patient safety and quality of care [
16]. Therefore, establishing an independent and structured role for pediatric sedation nurses, along with providing systematic evidence for standardized nursing practices, is essential to ensure safe, effective, and professional sedation care in inpatient settings.
This study aimed to describe the general, clinical, and sedation-related characteristics of hospitalized pediatric patients who received procedural sedation by pediatric sedation nurses in a tertiary hospital, and to assess the incidence of adverse events and sedation failure. The findings are expected to provide foundational data for developing standardized pediatric sedation nursing practices in South Korea, support the formalization of pediatric nurses’ roles, and contribute to patient safety and quality improvement.
METHODS
Ethical statements: This study was approved by the Institutional Review Board of Seoul National University Hospital (IRB No. 2312-011-1488). The requirement for informed consent was waived owing to the retrospective nature of the study.
1. Study Design
This retrospective descriptive study involved reviewing electronic medical records (EMRs) to identify the general, clinical, and sedation-related characteristics of pediatric patients who received procedural sedation from pediatric sedation nurses, and to determine the incidence of sedation-related adverse events and sedation failure. The reporting of this study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines [
17].
The sample comprised pediatric inpatients under the age of 18 who underwent procedural sedation exclusively performed by pediatric sedation nurses in the pediatric wards of Seoul National University Hospital, South Korea, between April 1 and September 30, 2023. Eligible participants were identified through a retrospective review of EMRs and sedation logs conducted by the first author, a pediatric sedation nurse at the study institution. The inclusion criteria were having received sedation for diagnostic or therapeutic procedures during hospitalization and the availability of complete sedation monitoring records. The participant selection and EMR data collection were conducted concurrently for the same study period. For patients who underwent multiple sedation episodes during the study period, only the first episode was included to avoid duplication.
Patients were excluded if sedation was not performed solely by pediatric sedation nurses, such as in angiographic procedures where radiology nurses were involved (n=175), or if the sedation record was incomplete (n=11). Additionally, patients whose medical records were restricted from review (n=1) or whose sedation process could not be continuously monitored owing to handover to a physician (n=2) were excluded. After applying these criteria, 585 patients were included in the final analysis.
At the study institution, procedural sedation was managed by a dedicated team of six pediatric sedation nurses. This team provided comprehensive sedation services across multiple clinical settings, including inpatient wards, outpatient clinics, and the radiology department. All team members had at least 5 years of pediatric nursing experience and completed regular sedation-related training, including mandatory annual pediatric sedation education and biennial Pediatric Advanced Life Support training. Their primary responsibilities within this study included pre-sedation assessment, sedative administration, continuous physiologic monitoring, and post-sedation recovery management according to standardized institutional guidelines.
3. Measurements
1) General and clinical characteristics
General characteristics included sex, age, weight, and body mass index. Age was categorized as <1 year, 1–<3 years, 3–<6 years, 6–<10 years, and ≥10 years. Body mass index was calculated as weight (kg) divided by height in meters squared (m2) using the measurement closest to the sedation date. Weight and height were measured by the nursing staff upon admission or during the hospitalization period using the standardized equipment available in each pediatric ward. For infants or children unable to stand, height was measured as recumbent length in a supine position.
Clinical characteristics included the department of admission and the American Society of Anesthesiologists (ASA) physical status classification [
18]. The department of admission was determined based on the primary physician responsible for sedation, including pediatric hematology-oncology, neurology, cardiology, thoracic surgery, neurosurgery, and other medical or surgical specialties. The ASA class is commonly used to assess sedation-related risk based on comorbidities, with patients classified as ASA III or higher being at increased risk for complications [
4]. To ensure consistency, ASA classes I–IV were assigned according to the pediatric-specific examples provided by the ASA rather than subjective judgment [
18].
2) Sedation-related characteristics
Participants’ sedation-related characteristics included the type and frequency of diagnostic or therapeutic procedures performed under procedural sedation, as well as the sedatives administered. Procedures were classified as noninvasive or invasive. Noninvasive procedures included electroencephalography, echocardiography, electrocardiography, ophthalmologic examination, hearing test, nuclear medicine test, magnetic resonance imaging (MRI), computed tomography (CT), ultrasonography, and electromyography. Invasive procedures included bone marrow examination, spinal tapping, and image-guided interventions (e.g., sono-guided biopsy/aspiration and CT-guided biopsy), among others. Sedation regimens were categorized as oral-only (chloral hydrate syrup), intravenous-only (midazolam, ketamine, or both), or combined oral and intravenous.
3) Adverse events and sedation failure
Adverse events were classified according to the definitions provided in the Quebec guidelines [
19]. Serious adverse events were defined as life-threatening complications requiring immediate medical intervention, such as apnea, laryngospasm, severe hypotension, bradycardia, complete airway obstruction, clinically evident pulmonary aspiration, permanent neurologic injury, or death [
19]. Adverse events referred to clinically significant but non-life-threatening events requiring intervention, including oxygen desaturation, vomiting, partial airway obstruction, myoclonus, paradoxical response, hypotension, seizure, and muscle rigidity [
19].
Sedation failure was defined as the inability to complete the planned diagnostic or therapeutic procedure owing to inadequate sedation, despite administration of the physician-prescribed sedative regimen, as evidenced by persistent inappropriate movements [
20]. Failures resulting from non-sedation-related causes were excluded from this definition.
Data were retrospectively collected from EMRs from December 2023 to April 2024. Data collection was conducted by the first author, a pediatric sedation nurse at the study hospital who was directly involved in clinical sedation care, ensuring a high level of familiarity with and accurate interpretation of the records. A standardized data collection sheet was developed based on an extensive literature review and was further refined through consultation with the corresponding author to ensure content validity. The extracted data included sedation records, clinical observation charts, nursing notes, medication administration records, and free-text notes documented by both pediatric sedation nurses and ward nurses, as sedation care in the pediatric wards is provided collaboratively.
To ensure data reliability, the first author performed a double-check of the extracted data by re-reviewing the original EMRs to verify accuracy and consistency. The data collection period for each case extended from the administration of sedatives to recovery, defined as return to baseline consciousness or a Modified Aldrete Score ≥9 [
21]. Multiple procedures performed within a single sedation session were also recorded. For patient confidentiality, all patient data were anonymized before analysis and securely stored in a password-protected file accessible only to the researcher, in accordance with institutional guidelines and relevant ethical standards.
Data were analyzed using IBM SPSS Statistics for Windows ver. 29.0 (IBM Corp.), with a significance level of p<.05. Descriptive statistics (frequencies, percentages, means, standard deviations) were used for participant characteristics, adverse events, and sedation failure. To examine associations between patient characteristics and the incidence of adverse events, chi-square tests or Fisher’s exact tests were used for categorical variables, and t-tests were used for continuous variables.
RESULTS
1. Participant Characteristics
Of the 585 patients included in the analysis, 59.3% were male, and the median age was 38 months. Most patients were categorized as ASA class II (43.1%) or III (48.9%). The most common admitting departments were hemato-oncology (17.9%), neurology (16.1%), and thoracic surgery (11.8%) (
Table 1).
Participants’ sedation-related characteristics are presented in
Table 2. A total of 671 procedures were performed, with echocardiography (18.3%), CT (15.1%), and MRI (14.0%) being the most common. A single procedure was performed in 86.8% of cases, and 13.2% underwent two or more procedures in a single sedation session. Sedatives were administered orally in 52.1% of cases, intravenously in 34.2%, and via combined oral and intravenous routes in 13.7%.
No adverse events occurred in 84.6% of the participants, and sedation was successful in 99.3% (
Table 3). The most frequent adverse event was oxygen desaturation (13.2%), followed by vomiting (2.6%). The most common interventions performed for adverse events were oxygen supplementation (12.1%) and airway repositioning (4.6%), with less frequent interventions including suction (1.9%) and bag-valve-mask ventilation (0.2%) (
Table 4).
The incidence of adverse events was significantly higher in patients in ASA class III–IV than in class I–II (χ
2=15.35,
p<.001). Patients admitted to neurology showed a higher adverse event rate compared with those from other departments (χ
2=7.10,
p=.008). Among procedure types, spinal tapping was associated with a significantly higher incidence of adverse events (χ
2=9.49,
p=.002). Multiple procedures in a single sedation session were linked to a higher adverse event incidence than a single procedure (χ
2=7.64,
p=.006). Combined oral and intravenous sedation was associated with a higher incidence compared with oral-only or intravenous-only (χ
2=53.82,
p<.001) (
Table 5).
DISCUSSION
This study examined pediatric inpatients who received procedural sedation by pediatric sedation nurses in a tertiary hospital, focusing on patient characteristics, sedation practices, adverse events, and sedation failure. Sedation was successful in 99.3% of the cases, and 84.6% of the patients experienced no adverse events, with no serious adverse events reported. These results demonstrate the overall safety and effectiveness of nurse-administered pediatric procedural sedation, as most children underwent sedation without complications and only a small proportion experienced mild, manageable events.
These findings are consistent with those of several international studies demonstrating that nurse-administered pediatric sedation can be performed safely and effectively when delivered as part of structured protocols and with appropriate clinical supervision. For example, Lavoie et al. [
22] in 2012 reported a 78% success rate and 13% incidence of mild adverse events among pediatric patients undergoing diverse diagnostic and therapeutic procedures under a nurse-led sedation program at a tertiary children’s hospital in Canada. In Belgium’s Pediatric Procedural Sedation and Analgesia program, trained nurses administered sedation for imaging and endoscopic procedures with a 98% success rate and only 2% adverse events, while high-risk patients (ASA III–IV) were excluded to maintain safety [
23]. Similarly, a 6-year nurse-led MRI sedation service in the United Kingdom achieved a 98.4% success rate with an overall adverse event incidence of approximately 3.5% when using dexmedetomidine, complemented by nonpharmacological sedation techniques [
12]. Although sedation outcomes may vary according to patient characteristics, clinical settings, or sedative regimens, these studies consistently demonstrate that structured nurse-led pediatric sedation programs can be implemented safely and effectively across different healthcare systems.
In the study institution, pediatric sedation nurses serve as integral members of a dedicated sedation team operating under the clinical governance of the Department of Anesthesiology and Pain Medicine. This supervision primarily focuses on the development and oversight of standardized sedation protocols and safety frameworks. While anesthesiologists are not continuously present at the bedside during sedation procedures, medical support is readily accessible through an established consultation and emergency response system. Within this framework, pediatric sedation nurses provide independent and continuous bedside care throughout the sedation process, including systematic monitoring of vital signs and ongoing clinical assessment before, during, and after sedation. This structured approach contributes to the high completion rate and low incidence of clinically significant adverse events observed in this medically complex inpatient population, further supporting the feasibility and safety of nurse-delivered procedural sedation in similar settings.
Accordingly, sedation practices were analyzed across a range of procedures performed in hospitalized children. Among the 671 procedures performed, echocardiography, CT, and MRI were the most common. Of the patients, 13.2% underwent two or more procedures during a single sedation session. This finding aligns with the results of Swann-Thomsen et al. [
24] in 2024, who reported that consolidating multiple procedures under a single sedation session reduces repeated sedative exposure, minimizes fasting-related discomfort, and enhances overall efficiency for patients, families, and healthcare systems. In this study, such integration reflects coordinated efforts among sedation nurses, ward nurses, referring departments, and clinical examination units. By reducing the physical and psychological burden on both the children and their caregivers, this integrated approach may support the principles of patient- and family-centered care.
Analysis of adverse event incidence identified several factors associated with increased risk. Male patients showed a higher incidence of adverse events, although prior studies have reported mixed results regarding sex differences [
25-
27]. Given these discrepancies, further large-scale studies are warranted to clarify the role of sex in sedation-related risk. More than half of the patients were categorized as ASA class III or IV, indicating a substantial proportion of high-risk children with severe systemic disease. Adverse events occurred more frequently in this group compared with lower ASA classes, consistent with previous studies reporting a higher incidence of adverse events in medically complex patients [
28]. These findings underscore the need for more vigilant monitoring and tailored nursing management strategies in high-risk pediatric populations to ensure procedural safety.
Patients admitted to the pediatric neurology department demonstrated a higher incidence of adverse events, consistent with studies indicating increased risk among patients with neurological or developmental disorders [
29]. Although the association was not statistically significant among patients admitted to neurosurgery, a similar trend was observed, suggesting that children with neurological conditions may be more susceptible to sedation-related complications. These findings highlight the need for vigilant monitoring and individualized nursing care during sedation in this population.
Spinal tapping showed a higher incidence of adverse events compared with other procedures. During this procedure, patients are required to maintain a flexed posture, and excessive neck flexion has been associated with physiological instability such as hypoxemia [
30]. When sedatives are administered, airway maintenance in this posture can be particularly challenging, which may increase the likelihood of complications. Therefore, careful positioning with minimal neck flexion is essential to maintain airway patency and ensure patient safety. In addition, the higher rate of adverse events observed in spinal tapping may partly reflect the characteristics of patients who typically undergo this procedure, such as those with neurological conditions. These findings suggest that procedure-specific sedation nursing that carefully considers both patient-related risk factors and procedural positioning is essential for maintaining safety during spinal tapping.
Although echocardiography and image-guided procedures demonstrated a significantly lower incidence of adverse events, this may have been influenced by the frequency effect related to the large number of cases rather than a true clinical difference. In contrast, MRI and CT showed relatively higher proportions of adverse events, but the differences were not statistically significant, likely owing to the limited sample size. Future multicenter studies with larger samples are warranted to clarify these procedure-specific patterns and confirm their clinical relevance.
Performing multiple procedures during a single sedation session was associated with an increased risk of adverse events. This finding is consistent with previous reports in pediatric oncology, where combined spinal tapping and bone marrow aspiration required higher drug doses and were linked to more frequent complications [
31]. Although consolidating procedures can reduce the total number of sedation episodes and enhance efficiency, these advantages must be carefully weighed against the potential risks, as highlighted by prior studies reporting increased sedative use and adverse events during multiple procedures [
31]. These findings emphasize the importance of sedation provider expertise and the establishment of evidence-based sedation protocols to optimize sedation safety and minimize unnecessary pharmacologic burden.
Finally, combined oral and intravenous sedation was associated with increased adverse events, aligning with the report by Choi et al. [
26] in 2021, further underscoring the role of combined drug use as a potential risk factor. Taken together, these findings emphasize the importance of recognizing high-risk characteristics that may predispose patients to adverse outcomes, thereby reinforcing the need for vigilant monitoring and tailored risk mitigation strategies in pediatric sedation nursing practice.
Sedation failure occurred in four out of 585 patients, all of whom were categorized as ASA class III and experienced sedation-related adverse events. In these cases, adequate sedation depth was not achieved despite additional sedatives, or the procedures were discontinued owing to adverse events that precluded further medication administration. As adverse events compromise physiologic stability and limit further sedative use, sedation failure and adverse events appear closely interrelated. This finding underscores the need for a systematic approach to the prevention and management of adverse events to ensure safe and successful procedural outcomes.
Sedation failure occurred during procedures such as MRI (n=2), spinal tapping (n=1), and hearing test (n=1), which generally require a deeper level of sedation and prolonged immobility. Continuous movement during MRI in one case prevented the maintenance of an adequate sedation level, suggesting that patient movement may also contribute to sedation failure. Recent evidence by Lin et al. [
12] in 2023 demonstrated that minimizing sensory stimulation—such as dimming lights, reducing ambient noise, and avoiding unnecessary tactile interventions—can help maintain immobility and prevent arousal during pediatric MRI sedation. These findings highlight the importance of incorporating nonpharmacological strategies into sedation nursing practice to minimize agitation and movement-related interruptions. As the required depth of sedation varies by procedure, individualized sedation planning and close monitoring remain essential for ensuring safe and effective pediatric procedural sedation.
This study has inherent limitations associated with its retrospective, single-center design, which may restrict generalizability and preclude causal inferences. Specifically, the study was conducted at a comprehensive children’s hospital within a tertiary medical center in Seoul, equipped with dedicated pediatric sedation nurses and a structured anesthesiology support system. Therefore, caution is warranted when generalizing these findings to clinical settings with different levels of resources and staffing, such as smaller community hospitals or general wards that lack specialized sedation teams. Furthermore, as the analysis relied on medical records, the accuracy of documentation regarding sedation depth, patient comfort, and delayed adverse events may have been limited, and nonpharmacological interventions were not captured. Crucially, as this study relied solely on univariable analyses to explore associations, the results should be interpreted with caution. Potential confounding factors could not be fully controlled, meaning the observed associations may not represent independent effects. Additionally, the exclusion of angiography cases may have underestimated risks related to invasive procedures. Although adverse events were analyzed according to ASA classification and department of admission, comorbidity-based analyses were not performed. Future multicenter prospective studies including standardized sedation scales and comorbidity profiles are warranted to comprehensively evaluate the quality and safety of pediatric sedation nursing.
CONCLUSION
This study demonstrates that procedural sedation administered by pediatric sedation nurses was performed safely and effectively for hospitalized children with various characteristics. Particular attention should be paid to high-risk groups, such as patients with higher ASA class, who have neurological conditions, who are undergoing spinal tapping or multiple procedures, and who are receiving combined-route sedation, who demonstrated increased susceptibility to adverse events.
Based on these findings, future multicenter studies are needed to validate and generalize the results across diverse clinical settings and to establish standardized pediatric sedation nursing practices. In addition, prospective studies using standardized and validated sedation assessment tools, while incorporating detailed comorbidity analyses, are warranted to more comprehensively evaluate the quality and safety of pediatric sedation nursing. Furthermore, as newer sedative agents such as intranasal dexmedetomidine are increasingly applied in pediatric practice for their favorable safety and efficacy profiles, additional research should explore their integration into nurse-administered sedation protocols.
Such research may contribute to the development of evidence-based guidelines, promote quality and safety improvement in pediatric sedation practice, and support the formal recognition of pediatric sedation nursing as a specialized area of practice.
ARTICLE INFORMATION
Table 1.General and clinical characteristics of the participants (N=585)
|
Characteristic |
Value |
|
Sex |
|
|
Male |
347 (59.3) |
|
Female |
238 (40.7) |
|
Age (mo) |
60.7±60.2 (38) |
|
Age group (yr) |
|
|
<1 |
155 (26.5) |
|
1–3 |
129 (22.1) |
|
3–6 |
110 (18.8) |
|
6–10 |
80 (13.7) |
|
≥10 |
111 (19.0) |
|
Weight (kg) |
21.0±17.8 |
|
Body mass index (kg/m2) |
17.3±3.4 |
|
ASA class |
|
|
Ⅰ |
28 (4.8) |
|
Ⅱ |
252 (43.1) |
|
Ⅲ |
286 (48.9) |
|
Ⅳ |
19 (3.2) |
|
Department |
|
|
Hemato-oncology |
105 (17.9) |
|
Neurology |
94 (16.1) |
|
Cardiology |
44 (7.5) |
|
Others (internal medicine) |
126 (21.5) |
|
Thoracic surgery |
69 (11.8) |
|
Neurosurgery |
66 (11.3) |
|
Others (surgery) |
81 (13.8) |
Table 2.Sedation-related characteristics of the participants (N=585)
|
Variable |
N (%) |
|
Type of proceduresa) (n=671) |
|
|
Non-invasive |
|
|
Electroencephalography |
66 (9.8) |
|
Echocardiography |
123 (18.3) |
|
Electrocardiography |
15 (2.2) |
|
Ophthalmologic exam |
34 (5.1) |
|
Hearing test |
20 (3.0) |
|
Nuclear medicine test |
26 (3.9) |
|
Magnetic resonance imaging |
94 (14.0) |
|
Computed tomography |
101 (15.1) |
|
Ultrasonography |
3 (0.4) |
|
Electromyography |
8 (1.2) |
|
Invasive |
|
|
Bone marrow exam |
61 (9.1) |
|
Spinal tapping |
45 (6.7) |
|
Image-guided procedure |
69 (10.3) |
|
Othersb)
|
6 (0.9) |
|
No. of procedures per case |
|
|
1 |
508 (86.8) |
|
≥2 |
77 (13.2) |
|
Characteristics of procedures |
|
|
Non-invasive |
411 (70.3) |
|
Invasive |
169 (28.9) |
|
Both |
5 (0.9) |
|
Sedative used |
|
|
PO only |
305 (52.1) |
|
IV only |
200 (34.2) |
|
PO + IV |
80 (13.7) |
Table 3.Incidence of sedation-related adverse events and sedation failure (N=585)
|
Variable |
N (%) |
|
Adverse events |
|
|
None |
495 (84.6) |
|
Adverse events |
90 (15.4) |
|
Serious adverse events |
0 (0.0) |
|
Sedation outcome |
|
|
Sedation success |
581 (99.3) |
|
Sedation failure |
4 (0.7) |
Table 4.Symptoms of and interventions for adverse events (N=90)
|
Variable |
N (%) |
|
Symptoms of adverse events (n=96) |
|
|
Oxygen desaturation |
77 (13.2) |
|
Vomiting |
15 (2.6) |
|
Partial airway obstruction |
2 (0.3) |
|
Myoclonus |
1 (0.2) |
|
Paradoxical response |
1 (0.2) |
|
Interventions for adverse events (n=110) |
|
|
Oxygen supplementation |
71 (12.1) |
|
Airway repositioning |
27 (4.6) |
|
Suction |
11 (1.9) |
|
Bag-valve-mask ventilation |
1 (0.2) |
Table 5.Comparison of sedation-related adverse events according to patient characteristics (N=585)
|
Characteristic |
No AE (n=495) |
Any AE (n=90) |
χ2/t |
p
|
|
Sex |
|
|
5.03*
|
.025 |
|
Male |
284 (57.4) |
63 (70.0) |
|
|
|
Female |
211 (42.6) |
27 (30.0) |
|
|
|
Age (mo) |
60.6±61.0 |
60.8±55.8 |
–0.03 |
.974 |
|
Age group (yr) |
|
|
2.79 |
.593 |
|
<1 |
131 (26.5) |
24 (26.7) |
|
|
|
1–3 |
113 (22.8) |
16 (17.8) |
|
|
|
3–6 |
91 (18.4) |
19 (21.1) |
|
|
|
6–10 |
64 (12.9) |
16 (17.8) |
|
|
|
≥10 |
96 (19.4) |
15 (16.7) |
|
|
|
Weight (kg) |
21.1±18.2 |
20.1±15.5 |
0.48 |
.635 |
|
Body mass index (kg/m2) |
17.3±3.3 |
17.4±4.1 |
–0.15 |
.882 |
|
ASA class |
|
|
15.35**
|
<.001 |
|
Ⅰ and Ⅱ |
254 (51.3) |
26 (28.9) |
|
|
|
Ⅲ and Ⅳ |
241 (48.7) |
64 (71.1) |
|
|
|
Department |
|
|
|
|
|
Hemato-oncology |
92 (18.6) |
13 (14.4) |
0.89 |
.346 |
|
Neurology |
71 (14.3) |
23 (25.6) |
7.10**
|
.008 |
|
Cardiology |
36 (7.3) |
8 (8.9) |
0.29 |
.593 |
|
Others (internal medicine) |
113 (22.8) |
13 (14.4) |
3.17 |
.075 |
|
Thoracic surgery |
60 (12.1) |
9 (10.0) |
0.33 |
.566 |
|
Neurosurgery |
51 (10.3) |
15 (16.7) |
3.08 |
.079 |
|
Others (surgery) |
72 (14.5) |
9 (10.0) |
1.32 |
.251 |
|
Non-invasive procedures |
|
|
|
|
|
Electroencephalography |
54 (10.9) |
7 (7.8) |
0.80 |
.371 |
|
Echocardiography |
79 (16.0) |
5 (5.6) |
6.70*
|
.010 |
|
Ophthalmologic exam |
15 (3.0) |
2 (2.2) |
0.18 |
1.000a)
|
|
Hearing test |
16 (3.2) |
1 (1.1) |
1.21 |
.492a)
|
|
Nuclear medicine test |
16 (3.2) |
3 (3.3) |
0.002 |
1.000a)
|
|
Magnetic resonance imaging |
57 (11.5) |
17 (18.9) |
3.75 |
.053 |
|
Computed tomography |
53 (10.7) |
13 (14.4) |
1.06 |
.303 |
|
Electromyography |
5 (1.0) |
3 (3.3) |
3.05 |
.110a)
|
|
Invasive procedures |
|
|
|
|
|
Bone marrow exam |
50 (10.1) |
5 (5.6) |
1.85 |
.174 |
|
Spinal tapping |
24 (4.8) |
12 (13.3) |
9.49**
|
.002 |
|
Image-guided procedure |
65 (13.1) |
1 (1.1) |
10.99**
|
<.001 |
|
Others |
4 (0.8) |
1 (1.1) |
0.083 |
.568a)
|
|
No. of procedures per case |
|
|
7.64**
|
.006 |
|
1 |
438 (88.5) |
70 (77.8) |
|
|
|
≥2 |
57 (11.5) |
20 (22.2) |
|
|
|
Sedative used |
|
|
53.82**
|
<.001 |
|
PO only |
276 (55.8) |
29 (32.2) |
|
|
|
IV only |
173 (34.9) |
27 (30.0) |
|
|
|
PO+IV |
46 (9.3) |
34 (37.8) |
|
|
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