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

Sex: All

Ages: 3 Years – 17 Years

Healthy volunteers: Yes

Phase: NA

Enrollment: 200

Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Location: Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo Alessandria Piedmont

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.

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07686029). StuddyBuddy aggregates publicly available trial information.