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

Trial Summary

What is the purpose of this trial?

According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake. This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure. The investigators believe that the information from this study will help establish a comprehensive NPO guideline.

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.

What data supports the effectiveness of the treatment Clear Fluids for Fasting in Children?

Research suggests that shorter fasting times for clear fluids, like apple juice, do not increase the risk of complications before surgery in children. Studies show that fasting for 2 hours after drinking clear fluids can be safe and may prevent negative effects like increased fat breakdown, which can happen with longer fasting. ^{1 2 3 4 5}

Is it safe for children to consume clear fluids before surgery?

Yes, it is generally safe for children to consume clear fluids up to 1 hour before surgery. Studies show that this does not increase the risk of complications and can make children more comfortable and less anxious. ^{2 3 4 6 7}

How is the clear fluids fasting treatment for children unique compared to other fasting methods?

The clear fluids fasting treatment for children is unique because it allows children to drink clear liquids like water, pulp-free juice, and tea without milk up to 1 hour before surgery, reducing thirst, hunger, and anxiety without increasing the risk of complications, unlike traditional longer fasting times. ^{1 2 3 4 7}

Research Team

Patcharee Sriswasdi, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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.

I am in good health or have mild systemic disease.

IPD cases or the first OPD case

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Using quality improvement methods to reduce clear fluid fasting times in children on a preoperative ward. [2018]

2. France pubmed.ncbi.nlm.nih.gov

Ultrasonographic evaluation of gastric emptying after ingesting carbohydrate-rich drink in young children: A randomized crossover study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Decreasing pre-procedural fasting times in hospitalized children. [2023]

4. England pubmed.ncbi.nlm.nih.gov

An ultrasound assessment of gastric emptying following tea with milk in pregnancy: A randomised controlled trial. [2021]

5. England 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. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

CHANGING PARADIGMS IN PREOPERATIVE FASTING: RESULTS OF A JOINT EFFORT IN PEDIATRIC SURGERY. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Consensus statement on clear fluids fasting for elective pediatric general anesthesia. [2019]