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RECRUITING
NCT07686029
NA

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

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

View on ClinicalTrials.gov

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.

Official title: Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery: A Pilot Randomized Controlled Study

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-09-03

Completion Date

2027-06

Last Updated

2026-07-06

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Maltodextrin Clear Liquid

Administration of 125 mL of a clear liquid containing maltodextrins two hours before elective pediatric surgery as part of the ERAS preoperative fasting protocol.

OTHER

Non-Sugared Clear Liquid

Administration of 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective pediatric surgery.

Locations (1)

Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, Italy