Reducing Fasting Time in Children for Sedation

Not Applicable

Completed

• Conditions: Pediatric ALL
• Interventions: Other: 4 hours of fasting time; Other: 2 hours of fasting time

• Registration Number: NCT05757882
• Lead Sponsor: Eunah Cho, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-03-07
• Study Start: 2023-05-25
• Primary Completion: 2023-08-07
• Study Completion: 2023-08-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• pediatric patients aged under 36 months
• scheduled for elective cardiac echocardiography

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4H	4 hours of fasting time	Participants who are following the standard fasting time (4 hours).
2H	2 hours of fasting time	Participants who are following minimized fasting time (2 hours)

Primary Outcome Measures

Name	Time	Method
Risk of aspiration	10 minutes before sedation	Gastric antral cross-sectional area assessed with gastric ultrasound

Secondary Outcome Measures

Name	Time	Method
The incidence of complications	10 minutes after sedation	he incidence of major (pulmonary aspiration, aspiration pneumonia) and minor complications (nausea and vomiting, dehydration) between two groups.

Trial Locations

Locations (1)

Jinyoung Song; 🇰🇷 Seoul, Gangnam, Korea, Republic of