Pediatric ALL
Conditions
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.
Interventions
Oral intake is not allowed for 4 hours before sedation including water.
OTHER2 hours of fasting time
Oral intake is not allowed for 2 hours before sedation including water.
Sponsors
Samsung Medical Center
Eunah Cho, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of aspiration | 10 minutes before sedation | Gastric antral cross-sectional area assessed with gastric ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed