Maltodextrin in the Preoperative Fast for Kids in ERAS
Official title: Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery: A Pilot Randomized Controlled Study
Run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · NCT07686029 · Data updated 2026-11-12
This pilot study tests whether giving maltodextrin before surgery helps reduce anxiety and improve recovery in children aged 3 to 8 undergoing elective day surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria Academic / other |
| Locations | 1 site (Alessandria, Piedmont) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | May 2027 |
| Study ends | June 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07686029 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3 to 8 years undergoing elective day surgery with procedures expected to last under 60 minutes.
✕Probably not a fit
Patients with maltodextrin intolerance, diabetes or other metabolic disorders, or those who recently consumed maltodextrin may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this single-center randomized pilot trial, pediatric patients 3 to 8 years old scheduled for elective day surgery are assigned to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid about two hours before anesthesia within an ERAS protocol. The study will measure preoperative anxiety, parental anxiety, oxidative stress markers, feeding tolerance after surgery, vomiting, pain, and readiness for discharge. It aims to determine whether carbohydrate loading in children is feasible and beneficial in the perioperative period. Outcomes will be analyzed to inform future larger studies in pediatric ERAS pathways.
Why it matters
Potential benefit: If successful, children may experience lower preoperative anxiety and smoother recovery, with potential benefits in feeding tolerance and discharge readiness.
How similar studies have gone: Prior adult studies suggest benefits of preoperative carbohydrates, but pediatric data are limited and this trial addresses that gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients aged 3 to 17 years * Patients undergoing elective surgery in a day surgery setting * Surgical procedure duration less than 60 minutes * Written informed consent signed by a parent or legal guardian Exclusion Criteria: * Maltodextrin intake within 3 hours before surgery * Allergy or intolerance to maltodextrins * Diabetes mellitus or other metabolic disorders potentially affecting study variables * Inadequate nutritional status based on body mass index (BMI) * Absence of signed informed consent by parent or legal guardian
Where it's running
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Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, Italy Recruiting
Study contacts
- Study coordinator: Clinical Trial Center
- Email: clinicaltrialcenter@ospedale.al.it
- Phone: 0131206893
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.