Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery (NCT07686029) | Clinical Trial Compass
RecruitingNot Applicable
Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery
Italy200 participantsStarted 2025-09-03
Plain-language summary
This monocentric prospective randomized controlled pilot study aims to evaluate the effectiveness of preoperative maltodextrin administration within an Enhanced Recovery After Surgery (ERAS) protocol in pediatric surgical patients. Children aged 3 to 8 years undergoing elective day surgery will be randomized 1:1 to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid before surgery. The study will assess preoperative anxiety, patient compliance, parental anxiety, oxidative stress markers, postoperative feeding tolerance, and postoperative recovery outcomes.
Who can participate
Age range
3 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
Timeframe: 20 to 30 minutes before surgery
Trial details
NCT IDNCT07686029
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria