Clear Fluids for Fasting in Children

Overseen By Sirirat Rattanaarpa, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Emergent EGD, Upper GI bleeding, GERD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal amount of clear fluids (such as water, pulp-free juice, tea without milk, or coffee without milk) for children aged 13 to 17 before an upper GI endoscopy, a procedure that examines the upper digestive system. Researchers are testing four different fluid amounts to identify the safest and most effective option. Participants will be randomly assigned to one of four groups, each consuming a specific amount of clear fluid two hours before their procedure. This trial is ideal for generally healthy children scheduled for an elective endoscopy at Boston Children's Hospital. The results will help establish better guidelines for fluid intake before surgery. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance pre-surgery guidelines for children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients who have received preoperative oral medication. This might mean you need to avoid taking certain medications before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that children can safely stop drinking clear fluids like water or juice for short periods. The American Society of Anesthesiologists (ASA) recommends avoiding clear fluids for 2 hours before surgery. This guideline relies on evidence that this fasting time does not increase the risk of complications such as stomach contents entering the lungs.

Studies have found that children often abstain from these liquids longer than necessary. However, consuming clear fluids within the recommended short period is safe. Fasting from clear fluids before surgery does not lead to more complications, making it a generally well-tolerated practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of allowing children to consume clear fluids just two hours before surgery, which challenges the traditional fasting guidelines. Typically, children are required to fast from midnight before surgery to reduce the risk of aspiration, but this can lead to dehydration and irritability. This trial aims to see if consuming different amounts of clear fluids (3, 5, 7, or 10 ml/kg) closer to surgery time can maintain safety while improving comfort and hydration. If successful, it could lead to a significant change in pre-surgical care for children, making the process less stressful and healthier for young patients.

What evidence suggests that this trial's treatments could be effective for fasting in children?

Studies have shown that children often fast longer than necessary before surgeries, leading to discomfort, thirst, and anxiety. The American Society of Anesthesiologists recommends stopping clear fluids like water and juice 2 hours before surgery. Research suggests that the amount consumed during this period affects the residual stomach liquid. This trial will compare different amounts of clear fluids—3 ml/kg, 5 ml/kg, 7 ml/kg, and 10 ml/kg—to determine the safest way to reduce stomach content. Allowing children to drink clear fluids until an hour before anesthesia may increase comfort without increasing risk. ^{1 2 3 4 6}

Who Is on the Research Team?

Patcharee Sriswasdi, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 13 and 17 years old.

IPD cases or the first OPD case

I am in good health or have mild systemic disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-procedure Preparation

Participants are randomly assigned to consume a specific volume of clear oral fluid 2 hours before the scheduled EGD procedure

2 hours

1 visit (in-person)

Procedure

Participants undergo the elective upper GI endoscopy procedure, during which gastric volume and pH are measured

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including incidence of pulmonary aspiration

24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clear oral fluid

Trial Overview 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.

How Is the Trial Designed?

Group I: 7 ml/kg of clear oral fluid Active Control 1 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 fluid Active Control 1 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 fluid Active Control 1 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 fluid Active Control 1 Intervention

This group of patient will consume 5 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time

Clear oral fluid is already approved in United States, European Union for the following indications:

Approved in United States as Clear oral fluid for:

• Preoperative hydration for elective surgery

Approved in European Union as Clear oral fluid for:

• Preoperative hydration for elective surgery

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

In a study involving 16 children aged 3-7 years, it was found that a carbohydrate-rich drink empties from the stomach more slowly than a 5% glucose solution, with significant differences in gastric fluid volume observed at 60 minutes after ingestion.

Despite the slower gastric emptying of the carbohydrate-rich drink, both drinks had low residual gastric fluid volume one hour after ingestion, suggesting that a 1-hour fasting time for clear liquids before surgery may be safe for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonographic evaluation of gastric emptying after ingesting carbohydrate-rich drink in young children: A randomized crossover study. Zhang, YL., Li, H., Zeng, H., et al.[2021]

A quality improvement project at a pediatric hospital successfully reduced the mean fasting time for clear fluids in children from 6.3 hours to 3.1 hours, significantly improving their preoperative comfort and stability.

The percentage of children fasting for less than 4 hours increased from 19% to 72%, without any increase in aspiration rates or cancellations, demonstrating the safety and efficacy of the implemented changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using quality improvement methods to reduce clear fluid fasting times in children on a preoperative ward. Newton, RJG., Stuart, GM., Willdridge, DJ., et al.[2018]

In a study involving 50 non-laboring pregnant women, the gastric emptying of tea with milk was found to be similar to that of water, indicating that milk does not significantly slow gastric emptying in this population.

Both tea with milk and water returned to baseline gastric measurements within 90 minutes, suggesting that including a small amount of milk in clear fluids could be considered safe for peri-operative fasting guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ultrasound assessment of gastric emptying following tea with milk in pregnancy: A randomised controlled trial. Irwin, R., Gyawali, I., Kennedy, B., et al.[2021]

A quality improvement initiative successfully reduced the average pre-procedural clear liquid fasting time for children from 10 hours 13 minutes to 6 hours 7 minutes, enhancing patient and family satisfaction.

The intervention was implemented safely, with no aspiration events reported and only four NPO violations during the study period, indicating that the new fasting guidelines did not compromise patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing pre-procedural fasting times in hospitalized children. Carroll, AR., McCoy, AB., Modes, K., et al.[2023]

In a study of 105 unpremedicated children aged 1-14 years, fasting for 2 hours after consuming apple juice did not increase gastric fluid volume or decrease pH compared to longer fasting intervals of 4 and 12 hours.

Longer fasting periods (4 and 12 hours) led to increased lipolysis to maintain blood sugar levels, suggesting that a 2-hour fasting period may be safer by preventing unnecessary metabolic changes without compromising gastric safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 2-, 4- and 12-hour fasting intervals on preoperative gastric fluid pH and volume, and plasma glucose and lipid homeostasis in children. Maekawa, N., Mikawa, K., Yaku, H., et al.[2022]

Current guidelines recommend a 2-hour fasting period for clear fluids before pediatric anesthesia, but evidence suggests that a 1-hour fasting policy is equally safe and does not increase the risk of pulmonary aspiration.

Allowing children to drink clear fluids up to 1 hour before surgery leads to less discomfort, reduced nausea and vomiting, and improved compliance, making the preoperative experience better for young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus statement on clear fluids fasting for elective pediatric general anesthesia. Thomas, M., Morrison, C., Newton, R., et al.[2019]

A study involving 31 children undergoing elective small to mid-size surgeries found that reducing pre-operative fasting to 2 hours with a carbohydrate-containing beverage is safe, with no adverse effects on anesthesia or surgery.

Early postoperative refeeding was also deemed safe, with only 6.5% of children experiencing vomiting, suggesting that this approach can be beneficial in pediatric surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHANGING PARADIGMS IN PREOPERATIVE FASTING: RESULTS OF A JOINT EFFORT IN PEDIATRIC SURGERY. Carvalho, CALB., Carvalho, AA., Nogueira, PLB., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10865513/

Preoperative clear fluids fasting times in children In this single pediatric center study, median clear fluids fasting time was three times higher (180 min) than those recommended by the preoperative fasting ...

2. asahq.org asahq.org/about-asa/newsroom/news-releases/2025/10/children-fast-from-clear-liquids-much-longer-before-surgery-than-guidelines-recommend

Children Fast From Clear Liquids Much Longer Before ... “Prolonged fasting from clear liquids of four hours or longer can be uncomfortable and increase thirst, anxiety, pain, nausea and vomiting,” ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03741777

Comparison of Residual Gastric Volume Between Children ... The ASA and ESA practice guidelines recommend a 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), a 4- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S152168962400017X

Preoperative fasting in children. The evolution of ... The major changes compared to previous guidelines were the recommendations to encourage children to drink clear fluids until 1 h before anesthesia induction, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8342827/

Pre-operative fasting times for clear liquids at a tertiary ... The main findings were that the median effective NPO time for clear liquids is excessively prolonged, only a minority of patients come in the OR earlier than ...

6. trialx.com trialx.com/clinical-trials/listings/319613/comparison-of-residual-gastric-volume-between-children-who-drink-different-clear-oral-fluid-volume/

Comparison of Residual Gastric Volume Between Children Who ... The ASA and ESA practice guidelines recommend a 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), a 4- ...