Reducing Fasting Time in Children for Sedation

Eunah Cho, MD

Status: Completed

Conditions: Pediatric ALL

Treatments: Other: 4 hours of fasting time; Other: 2 hours of fasting time

Study type: Interventional

Funder types: Other

Identifiers

NCT05757882

NPO2

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

4H

Active Comparator group

Description:

Participants who are following the standard fasting time (4 hours).

Treatment:

Other: 4 hours of fasting time

2H

Experimental group

Description:

Participants who are following minimized fasting time (2 hours)

Treatment:

Other: 2 hours of fasting time