Pediatric ALL Clinical Trial
Official title:
Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation
NCT number | NCT05757882 |
Other study ID # | NPO2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2023 |
Est. completion date | August 7, 2023 |
Verified date | September 2023 |
Source | Kangbuk Samsung Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jinyoung Song | Seoul | Gangnam |
Lead Sponsor | Collaborator |
---|---|
Eunah Cho, MD | Samsung Medical Center |
Korea, Republic of,
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 |
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