Reducing Fasting Time in Children for Sedation

September 19, 2023 updated by: Eunah Cho, MD

Comparison of Gastric Ultrasound for Reduction of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4H
Participants who are following the standard fasting time (4 hours).
Other: 4 hours of fasting time
Oral intake is not allowed for 4 hours before sedation including water.
Experimental: 2H
Participants who are following minimized fasting time (2 hours)
Other: 2 hours of fasting time
Oral intake is not allowed for 2 hours before sedation including water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of aspiration
Time Frame: 10 minutes before sedation
Gastric antral cross-sectional area assessed with gastric ultrasound
10 minutes before sedation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes after sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunah Cho, MD

Collaborators

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Actual)

August 7, 2023

Study Completion (Actual)

August 7, 2023

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NPO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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