Reducing Fasting Time in Children for Sedation

Pediatric ALL Clinical Trial

Official title:

Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757882
• Other study ID #: NPO2
• Status: Completed
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: August 7, 2023

Study information

• Verified date: September 2023
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 7, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric ALL

Intervention

Other:
• 4 hours of fasting time
Oral intake is not allowed for 4 hours before sedation including water.
• 2 hours of fasting time
Oral intake is not allowed for 2 hours before sedation including water.

Locations

Country	Name	City	State
Korea, Republic of	Jinyoung Song	Seoul	Gangnam

Sponsors (2)

Lead Sponsor	Collaborator
Eunah Cho, MD	Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of aspiration	Gastric antral cross-sectional area assessed with gastric ultrasound	10 minutes before sedation
Secondary	The incidence of complications	he incidence of major (pulmonary aspiration, aspiration pneumonia) and minor complications (nausea and vomiting, dehydration) between two groups.	10 minutes after sedation