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Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery

RecruitingNAAges 3 Years - 17 YearsAllAzienda Ospedaliera SS. Antonio e Biagio e Cesare…
NCT07686029 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Maltodextrin Clear Liquid
  • Non-Sugared Clear Liquid
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Where

1 site
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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