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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Maltodextrin Clear Liquid
  • Non-Sugared Clear Liquid

Treatment groups

200 Participants
are divided into 2 treatment groups