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.
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
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)
Parallel
Maltodextrin Clear Liquid
Dietary supplementAdministration of 125 mL of a clear liquid containing maltodextrins two hours before elective pediatric surgery as part of the ERAS preoperative fasting protocol.
Non-Sugared Clear Liquid
Other interventionAdministration of 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective pediatric surgery.
Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)
Evaluation of preoperative anxiety and agitation in pediatric surgical patients receiving maltodextrin-containing clear liquids compared with control patients receiving non-sugared clear liquids before elective surgery.
Postoperative pain assessed by Visual Analogue Scale (VAS)
Evaluation of postoperative pain using the Visual Analogue Scale (VAS) in pediatric patients after elective surgery.
Eligibility for discharge after surgery
Evaluation of the proportion of pediatric patients considered eligible for discharge 6 hours after elective surgery according to postoperative recovery and clinical conditions.
Evaluation of postoperative vomiting
Incidence of participants experiencing at least one episode of postoperative vomiting during the first 6 hours after surgery.
Preoperative oxidative stress
Blood chemistry tests for the assessment of preoperative stress
Click on the lead sponsor to view all of their trials.
