Clinical trial · Interventional
NPO Before Sedation
Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1 hour of fasting time | Other | — | UNRESOLVED |
| 4 hours of fasting time | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 4H group
- description
- fasting more than 4 hours before sedation
- interventionNames
- Other: 4 hours of fasting time
- type
- EXPERIMENTAL
- label
- 1H group
- description
- oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation
- interventionNames
- Other: 1 hour of fasting time
Primary outcomes (1)
- measure
- Gastric astral cross-sectional area
- timeFrame
- 10 minutes before sedation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 3 Years
Show eligibility criteria text
Inclusion Criteria: * Children scheduled for elective echocardiography * Aged under 3 years old Exclusion Criteria: * Comorbidity other than hear disease or chromosomal disease * Patients with delayed gastric emptying * Patients with structural abnormalities of the stomach or esophagus * Difficult airway management * Parents refuse to participate in the study * Unable to achieve sedation * Neonatal
References
Publications (1)
- DERIVEDCho 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. PMID 40530767