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Clear Fluids for Fasting in Children

N/A
Recruiting
Led By Patcharee Sriswasdi, MD, MPH
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
13-17 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up we will collect data on a day of surgery from patient's arrival until they are discharged from pacu upto 24 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to determine the optimal amount of clear fluids that children aged 13-17 years should consume before an upper GI endoscopy. The study will randomly assign participants into four groups to consume

Who is the study for?
This trial is for children aged 13-17 who are classified as ASA I or II, meaning they're healthy or have mild systemic disease. They must be scheduled for an elective upper GI endoscopy at Boston Children's Hospital and speak English fluently with their families or guardians.
What is being tested?
The study tests how different volumes of clear oral fluids affect residual gastric volume in fasting children before surgery. Participants will be randomly assigned to drink either 3, 5, 7, or 10 ml/kg of fluid two hours before their procedure to see which amount is best.
What are the potential side effects?
Since the intervention involves only drinking clear fluids like water or pulp-free juice, side effects are minimal but could include discomfort from fasting and potential anxiety about the upcoming procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~we will collect data on a day of surgery from patient's arrival until they are discharged from pacu upto 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and we will collect data on a day of surgery from patient's arrival until they are discharged from pacu upto 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gastric volume
Secondary study objectives
Gastric pH
Incidence of pulmonary aspiration

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: 7 ml/kg of clear oral fluidActive Control1 Intervention
This group of patient will consume 7 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
Group II: 10 ml/kg of clear oral fluidActive Control1 Intervention
This group of patient will consume 10 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
Group III: 3 ml/kg of clear oral fluidActive Control1 Intervention
This group of patient will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
Group IV: 5 ml/kg of clear oral fluidActive Control1 Intervention
This group of patient will consume 5 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,659 Total Patients Enrolled
2 Trials studying Fasting
210 Patients Enrolled for Fasting
Patcharee Sriswasdi, MD, MPHPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
340 Total Patients Enrolled
~128 spots leftby Sep 2025
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