NPO Before Sedation
Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
1 other identifier
interventional
68
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedStudy Start
First participant enrolled
May 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2023
CompletedApril 3, 2024
April 1, 2024
7 months
March 31, 2023
April 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Gastric astral cross-sectional area
Gastric astral cross-sectional area measured with gastric ultrasound
10 minutes before sedation
Secondary Outcomes (3)
Estimated gastric volume
10 minutes before sedation
Perlas grade
10 minutes before sedation
Quality of sdeation
10 minutes after sedation
Study Arms (2)
4H group
ACTIVE COMPARATORfasting more than 4 hours before sedation
1H group
EXPERIMENTALoral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation
Interventions
Oral intake is not allowed for 4 hours before sedation including water
Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation
Eligibility Criteria
You may qualify if:
- Children scheduled for elective echocardiography
- Aged under 3 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Related Publications (1)
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.
PMID: 40530767DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 31, 2023
First Posted
April 12, 2023
Study Start
May 4, 2023
Primary Completion
December 11, 2023
Study Completion
December 11, 2023
Last Updated
April 3, 2024
Record last verified: 2024-04