• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• Journal of Dental Anesthesia and Pain Medicine
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• v.23 no.6
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• pp.337-346
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• 2023

Background: This study aimed to investigate the effect of local anesthesia (LA) on postoperative pain and hemostasis after dental rehabilitation under general anesthesia (DRGA) in pediatric patients. Methods: A total of 43 patients, aged 3-7 years and rated ASA I or II, who had a definitely negative rating on Frankel's behavior rating scale, were included in this two-arm, parallel-design, single-blinded, randomized, controlled study. The patients were allocated equally into two main groups receiving both restorative treatments and tooth extractions. Two pain scales and one bleeding scale were used. In Group A, the treatment was done with LA, and in Group B, the treatment was done without LA. Results: The statistical analysis revealed no significant differences in the pain scores between the groups. It also revealed significant differences in the bleeding scores between the groups but no significant differences in the duration of bleeding. Conclusion: Within the limitations of this study, the use of LA in pediatric dental patients undergoing DRGA had no effects on postoperative pain reduction or bleeding duration after teeth extraction. We also observed that the use of LA had an impact on the reduction in the bleeding scores in pediatric dental patients undergoing DRGA.

• Clinical and Experimental Pediatrics
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• v.60 no.8
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• pp.237-244
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• 2017

During the last 10 years, there have been major technological achievements in pediatric interventional cardiology. In addition, there have been several advances in cardiac imaging, especially in 3-dimensional imaging of echocardiography, computed tomography, magnetic resonance imaging, and cineangiography. Therefore, more types of congenital heart diseases can be treated in the cardiac catheter laboratory today than ever before. Furthermore, lesions previously considered resistant to interventional therapies can now be managed with high success rates. The hybrid approach has enabled the overcoming of limitations inherent to percutaneous access, expanding the application of endovascular therapies as adjunct to surgical interventions to improve patient outcomes and minimize invasiveness. Percutaneous pulmonary valve implantation has become a successful alternative therapy. However, most of the current recommendations about pediatric cardiac interventions (including class I recommendations) refer to off-label use of devices, because it is difficult to study the safety and efficacy of catheterization and transcatheter therapy in pediatric cardiac patients. This difficulty arises from the challenge of identifying a control population and the relatively small number of pediatric patients with congenital heart disease. Nevertheless, the pediatric interventional cardiology community has continued to develop less invasive solutions for congenital heart defects to minimize the need for open heart surgery and optimize overall outcomes. In this review, various interventional procedures in patients with congenital heart disease are explored.

• Clinical and Experimental Pediatrics
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• v.53 no.3
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• pp.286-293
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• 2010

Peak bone mass is established predominately during childhood and adolescence. It is an important determinant of future resistance to osteoporosis and fractures to gain bone mass during growth. The issue of low bone density in children and adolescents has recently attracted much attention and the use of pediatric dual-energy X-ray absorptiometry (DXA) is increasing. The process of interpretation of pediatric DXA results is different from that of adults because normal bone mineral density (BMD) of children varies by age, body size, pubertal stage, skeletal maturation, sex, and ethnicity. Thus, an appropriate normal BMD Z-score reference value with Z-score should be used to detect and manage low BMD. Z-scores below -2.0 are generally considered a low BMD to pediatrician even though diagnoses of osteoporosis in children and adolescents are usually only made in the presence of at least one fragility fracture. This article will review the basic knowledge and practical guidelines on pediatric DXA based on the International Society for Clinical Densitometry (ISCD) Pediatric Official Positions. Also discussed are the characteristics of normal Korean children and adolescents with respect to BMD development. The objective of this review is to help pediatricians to understand when DXA will be useful and how to interpret pediatric DXA reports in the clinical practice for management of children with the potential to develop osteoporosis in adulthood.

• Child Health Nursing Research
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• v.6 no.1
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• pp.5-17
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• 2000

The purpose of this study was to provide qualified nursing care to examine the degree of satisfaction with nursing care of pediatric patients visiting emergency center. Data were collected from March, 8 to June, 5, 1999 from 304 subjects including 2 University hospitals located in Seoul. Using the 23 item questionnaire, which made out by Davis CHECSS tool through modification and supplement by researchers. The collected data were scored by use of means and standard deviations according to the degree of satisfaction with nursing care of pediatric patients visiting emergency center and each item as an independent variable was analysed by t-test and ANOVA test. The results are as follows. 1. The degree of satisfaction with the nursing care of pediatric patients visiting emergency center showed as an average of 3.69. 2. With the resept of general characteristics related to pediatric patients visiting emergency center, there were statiscally significant difference in duration of stay at emergency center(F=2.908, p=.014), type of disease(F=1.777, p=.046). The degree of satisfaction with the nursing care of pediatric patients of examiners showed relatively high, but emotional care and information supply are required.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.3
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• pp.107-118
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• 2020

Chloral hydrate is the oldest and most common sedative drug used in moderate sedation for pediatric dental patients. Hence, the purpose of this article is to review the safety and possible adverse events of this drug when used for pediatric dental treatment. A bibliographic search in PubMed, MEDLINE, Cochrane Library and KMbase, KISS, DBpia, KoreaMed, and RISS databases was performed. Using the keywords "dental sedation," "chloral hydrate," and "children or adolescent," 512 scientific articles were found. Subsequently, 183 studies were individually assessed for their suitability for inclusion in this literature review. Altogether, 24 studies were selected. They included 12 cases of death before, during, or after chloral hydrate sedation for dental treatment, majorly due to dosing error and use of multiple sedatives. Additionally, intraoperative adverse events were mostly respiratory problems such as hypoxia and apnea, but most events were temporary. After treatment, prolonged sedation, including excessive sleep and less activity were the most common postoperative adverse events, and even death cases were reported. Despite the wide acceptance of chloral hydrate as a sedative-hypnotic agent, the risk of adverse events and adequate dose should be of great concern when using it for pediatric dental sedation.

• The Journal of Churna Manual Medicine for Spine and Nerves
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• v.13 no.2
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• pp.23-34
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• 2018

Objectives : This review aims to evaluate the effects and the safety of Chuna manual therapy(CMT) for pediatric functional constipation. Methods : We searched 10 electronic databases(Pubmed, EMBASE, Cochrane Library, CAJ, Oasis, RISS, KISS, NDSL, KMBASE, KISTI) and related 2 journals until October 2018. We included randomized controlled trials(RCTs) of testing CMT for pediatric functional constipation. The methodological quality of RCTs related assessed by the Cochrane risk of bias tool. Results : 16 RCTs were eligible in our inclusion criteria. The meta-analysis of 11 studies showed positive for use CMT for pediatric functional constipation. CMT significantly improved total efficancy rate compared with medications (P < 0.00001). Conclusions : There is evidence of CMT for pediatric functional constipation with meta-analysis. However, our systematic review has limited evidence to support CMT for pediatric functional constipation. because the quality of relevant trials is relatively poor. Further well-designed RCTs should be encouraged. the quality of relevant trials is relatively poor.

• Clinical Nutrition Research
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• v.13 no.3
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• pp.149-155
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• 2024

Estimating the nutritional requirements for pediatric patients requires a comprehensive approach with various factors including age, gender, body mass index, and physical activity level, due to the significant growth and developmental changes observed in this population. This complexity renders the use of a simplistic generalization or a standard formula impractical. A number of methodologies have been established to calculate nutritional needs for the pediatric population. However, the application of these methodologies is challenging due to the variability in the aforementioned factors. Determining nutritional requirements for pediatric patients with underlying medical conditions is complicate, influenced by variables such as the nature of the illness, treatment modalities, and the patient's overall condition. Nutritional support in severely traumatically brain-injured pediatric patients is directly correlated with prognosis and growth outcomes. Therefore, this case study aims to validate existing methodologies for estimating nutritional requirements in pediatric patients with severe traumatic brain injury and to provide primary data for the development of effective nutritional support strategies. A case of a 5-year-old male patient admitted to the intensive care unit due to severe traumatic brain injury is examined. Future case studies and ongoing research are imperative to ensure the safe and effective nutritional support of pediatric patients with severe traumatic brain injury.

• Journal of the korean academy of Pediatric Dentistry
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• v.26 no.2
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• pp.240-247
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• 1999

Primary anterior teeth requiring extensive restorative therapy due to caries, trauma or developmental defects can present a particularly challenging problem for the pediatric dentist. The ideal restorative technique would combine strength, durability esthetics and efficiency in placement. Couple these concerns with the technical difficulties of operating on children with behavior management problems, and the dentist is left with the difficult task of choosing from a variety of restorative options. Restorative modalities currently in use to treat primary anterior teeth include bonding with composite resin as in celluloid strip crowns, conventional stainless steel crowns, open-faced stainless steel crowns, commercially and chairside veneered stainless steel crowns and epoxy-coated stainless steel crowns. Each of these techniques presents technical, functional or esthetic compromises that complicate their efficient and effective usage. This is a report of the results obtained at the Department of Pediatric Dentistry, College of Dentistry Seoul National University, through the use of these various methods of treating primary anterior teeth.

• Korean Journal of Clinical Pharmacy
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• v.28 no.3
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• pp.181-187
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• 2018

Background: Posaconazole is a broad-spectrum triazole antifungal agent and the most recommended prophylactic antifungal agent for patients with acute myeloid leukemia (AML) undergoing induction chemotherapy. In this study, we evaluated the status and effectiveness of posaconazole as a prophylactic antifungal agent in pediatric patients receiving induction chemotherapy for AML. Methods: We retrospectively reviewed the electronic medical records of 36 pediatric patients with AML (between January 2013 and September 2017) at the Yonsei University Health System. Invasive fungal disease (IFD) was assessed as the primary endpoint of prophylactic antifungal effect. The secondary endpoints were incidence of fever, persistent fever despite the use of broad-spectrum antibiotics for 72 h, alteration of antifungal agent, intensive care unit admission, and death within 100 days. Results: Among the 36 patients, 18 patients used posaconazole, 12 were treated with suspension formula, and 6 of them were treated with tablets. Eighteen patients did not use antifungal agents prophylactically. The mean number of days of posaconazole administration was $26.8{\pm}16days$. IFD occurred in 2/18 (11.1%) patients in the no prophylaxis group and in 1/18 (5.6%) patients in the posaconazole group (p=0.49). Conclusion: Posaconazole is expected to be useful for the prevention of IFD in pediatric patients with AML undergoing induction chemotherapy. Prospective studies of the effectiveness of posaconazole prophylaxis should be conducted in more pediatric patients in the future.