Clear Fluids for Fasting in Children
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Disqualifiers: Emergent EGD, Upper GI bleeding, GERD, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
23467How 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.
12347Eligibility 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
+2 more
Trial 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)
Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
References
Using quality improvement methods to reduce clear fluid fasting times in children on a preoperative ward. [2018]We applied quality improvement (QI) methodology to identify the different aspects of why children fasted for prolonged periods in our institution. Our aim was for 75% of all children to be fasted for clear fluid for less than 4 hours.
Ultrasonographic evaluation of gastric emptying after ingesting carbohydrate-rich drink in young children: A randomized crossover study. [2021]A recent consensus statement in Europe has suggested that the fasting time for clear liquid in children can be shortened to 1 hour before a surgery. However, the study to show that 1-hour fasting time for clear fluids is safe in young children is still lacking. This study aimed to investigate the gastric emptying time for carbohydrate-rich drink and regular 5% glucose solution in children aged 3-7 years.
Decreasing pre-procedural fasting times in hospitalized children. [2023]Prolonged pre-procedural fasting in children is associated with decreased patient and family satisfaction and increased patient hemodynamic instability. Practice guidelines recommend clear liquid fasting times of 2 h. We aimed to decrease pre-procedural clear liquid fasting time from 10 h 13 min to 5 h for pediatric hospital medicine (PHM) patients.
An ultrasound assessment of gastric emptying following tea with milk in pregnancy: A randomised controlled trial. [2021]Peri-operative fasting guidelines allow clear fluids including tea without milk to be consumed up to 2 h before surgery. Recent evidence has shown that a modest amount of milk consumed with clear fluids does not significantly slow gastric emptying.
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]We evaluated 105 randomly-selected unpremedicated children aged 1-14 years to determine the effects of a 2-, 4- and 12-h preoperative fasting interval on the preoperative gastric fluid pH and volume, and plasma glucose and lipid homeostasis. Each child undergoing elective surgery ingested a large volume (approximately 10 ml/kg b.w.) of apple juice and then fasted for 2, 4 or 12 h before the estimated induction of anaesthesia. After induction of anaesthesia, gastric fluid was aspirated through a large-bore, multiorifice orogastric tube. Plasma concentrations of glucose, total ketone bodies, non-esterified fatty acid (NEFA), triglycerides, and cortisol were measured at the time of induction to evaluate the fasting interval effects on preoperative plasma glucose and lipid homeostasis. There were no significant differences between the three groups in either gastric fluid volume or pH. In addition, there were no significant differences between the groups with respect to the proportion with a pH 0.4 ml/kg b.w. Neither plasma concentrations of glucose, triglycerides, nor cortisol at the time of anaesthetic induction differed between the three groups. Both 4 and 12 h nil per os (NPO) caused an increase in lipolysis, which was presumably a compensatory mechanism to maintain normoglycaemia. The plasma NEFA and total ketone bodies concentrations were therefore significantly higher in these two fasting intervals than in 2 h NPO. These data suggest that a 2-h NPO, after a large volume of ingested apple juice, may offer additional benefits by preventing an increase in lipolysis during the fasting interval without either increasing the volume of gastric fluid or decreasing the gastric pH.(ABSTRACT TRUNCATED AT 250 WORDS)
CHANGING PARADIGMS IN PREOPERATIVE FASTING: RESULTS OF A JOINT EFFORT IN PEDIATRIC SURGERY. [2022]Current researches associate long fasting periods to several adverse consequences. The fasting abbreviation to 2 h to clear liquids associated with the use of drinks containing carbohydrates attenuates endocrinometabolic response to surgical trauma, but often is observed children advised to not intake food from 00:00 h till the scheduled surgical time, regardless of what it is.
Consensus statement on clear fluids fasting for elective pediatric general anesthesia. [2019]Pediatric anesthetic guidelines for the management of preoperative fasting of clear fluids are currently 2 hours. The traditional 2 hours clear fluid fasting time was recommended to decrease the risk of pulmonary aspiration and is not in keeping with current literature. It appears that a liberalized clear fluid fasting regime does not affect the incidence of pulmonary aspiration and in those who do aspirate, the sequelae are not usually severe or long-lasting. With a 2-hour clear fasting policy, the literature suggests that this translates into 6-7 hours actual duration of fasting with several studies up to 15 hours. Fasting for prolonged periods increases thirst and irritability and results in detrimental physiological and metabolic effects. With a 1-hour clear fluid policy, there is no increased risk of pulmonary aspiration and studies demonstrate the stomach is empty. There is less nausea and vomiting, thirst, hunger, and anxiety, if allowed a drink closer to surgery. Children appear more comfortable, better behaved and possibly more compliant. In children less than 36 months this has positive physiological and metabolic effects. It is practical to allow children to drink until 1 hour prior to anesthesia on the day of surgery. In this joint consensus statement, the Association of Paediatric Anaesthetists of Great Britain and Ireland, the European Society for Paediatric Anaesthesiology, and L'Association Des Anesthésistes-Réanimateurs Pédiatriques d'Expression Française agree that, based on the current convincing evidence base, unless there is a clear contraindication, it is safe and recommended for all children able to take clear fluids, to be allowed and encouraged to have them up to 1 hour before elective general anesthesia.