Reducing Fasting Time in Children for Sedation
Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation
1 other identifier
interventional
100
1 country
1
Brief Summary
Patients are asked to be fasted for certain period of time before sedation to reduce the risk of pulmonary aspiration. However, fasting can be harmful, especially in children who has smaller reserves of energy and fluids compared to the adults. Prolonged fasting may increase nausea, vomiting, dehydration, and hypoglycemia. Therefore, it is important to minimize prolonged fasting time in pediatric patients. This study is aimed to investigate the safety of minimal fasting time (2 hours) compared to the standard fasting time (4 hours) with gastric ultrasound.
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
February 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 7, 2023
CompletedStudy Start
First participant enrolled
May 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2023
CompletedSeptember 21, 2023
September 1, 2023
2 months
February 24, 2023
September 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Risk of aspiration
Gastric antral cross-sectional area assessed with gastric ultrasound
10 minutes before sedation
Secondary Outcomes (1)
The incidence of complications
10 minutes after sedation
Study Arms (2)
4H
ACTIVE COMPARATORParticipants who are following the standard fasting time (4 hours).
2H
EXPERIMENTALParticipants who are following minimized fasting time (2 hours)
Interventions
Oral intake is not allowed for 4 hours before sedation including water.
Oral intake is not allowed for 2 hours before sedation including water.
Eligibility Criteria
You may qualify if:
- pediatric patients aged under 36 months
- scheduled for elective cardiac echocardiography
You may not qualify if:
- patients with disease that delay gastric emptying
- patients taking medication that delay gastric emptying
- structural deformities, or abnormalities that interrupt gastric ultrasound
- refuse to participate in the study
- sedation is failed or impossible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eunah Cho, MDlead
- Samsung Medical Centercollaborator
Study Sites (1)
Jinyoung Song
Seoul, Gangnam, South Korea
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
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 24, 2023
First Posted
March 7, 2023
Study Start
May 25, 2023
Primary Completion
August 7, 2023
Study Completion
August 7, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09