Reducing Fasting Time in Children for Sedation

NCT ID: NCT05757882

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2023-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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4H

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

Group Type ACTIVE_COMPARATOR

4 hours of fasting time

Intervention Type OTHER

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

2H

Participants who are following minimized fasting time (2 hours)

Group Type EXPERIMENTAL

2 hours of fasting time

Intervention Type OTHER

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

Interventions

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4 hours of fasting time

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

Intervention Type OTHER

2 hours of fasting time

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

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role collaborator

Eunah Cho, MD

OTHER

Sponsor Role lead

Responsible Party

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Eunah Cho, MD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jinyoung Song

Seoul, Gangnam, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NPO2

Identifier Type: -

Identifier Source: org_study_id

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