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OpenTrials
Completed

NCT Number: NCT05757882

Reducing Fasting Time in Children for Sedation

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.

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Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinyoung Song

Seoul, Gangnam, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 hours of fasting time

Other

Oral intake is not allowed for 4 hours before sedation including water.

2 hours of fasting time

Other

Oral intake is not allowed for 2 hours before sedation including water.

Primary outcomes

  1. Risk of aspiration

    Time frame: 10 minutes before sedation

    Gastric antral cross-sectional area assessed with gastric ultrasound

Secondary outcomes

  1. The incidence of complications

    Time frame: 10 minutes after sedation

    he incidence of major (pulmonary aspiration, aspiration pneumonia) and minor complications (nausea and vomiting, dehydration) between two groups.

Sponsors and collaborators

Lead sponsor

Eunah Cho, MD

Other

Collaborators

  • Samsung Medical Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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