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Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.
Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4H group | Active Comparator | fasting more than 4 hours before sedation |
|
| 1H group | Experimental | oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 hours of fasting time | Other | Oral intake is not allowed for 4 hours before sedation including water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric astral cross-sectional area | Gastric astral cross-sectional area measured with gastric ultrasound | 10 minutes before sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated gastric volume | Calculated gastric volume using the formula | 10 minutes before sedation |
| Perlas grade | Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40530767 | Derived | Cho E, Song J, Huh J, Kang IS, Kim HJ, Youn IY, Lee H, Kwak JH. Evaluation of Modified Fasting Protocols to Shorten Fasting Time Before Sedation in Children: A Prospective Randomized Noninferiority Trial. Paediatr Anaesth. 2025 Sep;35(9):753-760. doi: 10.1111/pan.15142. Epub 2025 Jun 18. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 1 hour of fasting time | Other | Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation |
|
| 10 minutes before sedation |
| Quality of sdeation | 0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling | 10 minutes after sedation |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |