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

NCT07686029 | Recruiting

• 1 other identifier: ASO.ChirPed.24.05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preoperative Care; Anxiety; Pediatric Surgery

Keywords

Enhanced Recovery After Surgery; ERAS; Maltodextrins; Preoperative Anxiety; Pediatric Surgery; Day Surgery; Carbohydrate Loading; Fasting; Randomized Controlled Trial; Modified Yale Preoperative Anxiety Scale; Postoperative Recovery; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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.

  20 to 30 minutes before surgery

Secondary Outcomes (6)

• Postoperative pain assessed by Visual Analogue Scale (VAS)

  2 hours after surgery

• Eligibility for discharge after surgery

  6 hours after surgery

• Evaluation of postoperative vomiting

  Within 6 hours after surgery

• Preoperative oxidative stress

  Immediately before surgery

• Preoperative stress assessed by State-Trait Anxiety Inventory - Form Y (STAI-Y)

  Immediate preoperative period

Study Arms (2)

Maltodextrin Group

EXPERIMENTAL

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

Dietary Supplement: Maltodextrin Clear Liquid

Control Group

PLACEBO COMPARATOR

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

Other: Non-Sugared Clear Liquid

Interventions

Maltodextrin Clear Liquid DIETARY_SUPPLEMENT

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

Also known as: Carbohydrate Loading, Maltodextrins

Maltodextrin Group

Non-Sugared Clear Liquid OTHER

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

Also known as: Placebo Beverage, Clear Liquid

Control Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

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

Study Sites (1)

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

Alessandria, Piedmont, 15121, Italy

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Fasting; Insulin Resistance

Interventions

Diet, Carbohydrate Loading

Condition Hierarchy (Ancestors)

Mental Disorders; Feeding Behavior; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Clinical Trial Center

CONTACT

0131206893; clinicaltrialcenter@ospedale.al.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid before elective surgery.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 6, 2026
• Study Start: September 3, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)