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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Preoperative Care, Anxiety, Pediatric Surgery

In brief

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.

Key facts

Study ID

NCT07686029

Run by

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

People needed

200

Starts

2025-09-03

Expected to finish

2027-06-01

Last updated by the study team

2026-07-06

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo — Alessandria, Piedmont, Italy (enrolling)

Full record on ClinicalTrials.gov

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