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NCT Number: NCT07686029

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

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.

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Key information

Conditions

Preoperative Care Anxiety Anxiety Disorders Behavior Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pediatric Surgery

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alessandria, Piedmont, 15121, Italy

Location status: Recruiting

Location contact

Pediatric Surgery Unit Clinical Trial Center

CONTACT

[email protected]

0131206893

About this study

Enhanced Recovery After Surgery (ERAS) protocols are multidisciplinary perioperative care programs developed to reduce surgical stress, improve postoperative recovery, and shorten hospital stay. In adult surgical populations, preoperative administration of carbohydrate-rich clear fluids has been associated with reduced insulin resistance, improved metabolic response, reduced postoperative nausea, and improved patient comfort.

Evidence regarding the use of these strategies in pediatric surgical patients remains limited. This prospective randomized controlled no-profit pilot study aims to evaluate the clinical impact of preoperative maltodextrin administration in children undergoing elective surgery.

Approximately 200 pediatric patients aged 3 to 8 years undergoing elective day surgery at the Pediatric Surgery Unit of the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo of Alessandria will be enrolled. Participants will be randomized 1:1 to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid two hours before surgery.

Primary outcome evaluation includes preoperative anxiety assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS). Secondary outcomes include parental anxiety, oxidative stress markers, postoperative feeding tolerance, postoperative vomiting, postoperative pain evaluation, and discharge eligibility after surgery.

Clinical, demographic, laboratory, anesthesiologic, and perioperative data will be collected and analyzed to assess the feasibility and effectiveness of this ERAS-based intervention in pediatric surgical patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Carbohydrate Loading, Maltodextrins

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.

Other names: Placebo Beverage, Clear Liquid

Primary outcomes

  1. Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS)

    Time frame: 20 to 30 minutes before surgery

    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.

Secondary outcomes

  1. Postoperative pain assessed by Visual Analogue Scale (VAS)

    Time frame: 2 hours after surgery

    Evaluation of postoperative pain using the Visual Analogue Scale (VAS) in pediatric patients after elective surgery.

  2. Eligibility for discharge after surgery

    Time frame: 6 hours 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.

  3. Evaluation of postoperative vomiting

    Time frame: Within 6 hours after surgery

    Incidence of participants experiencing at least one episode of postoperative vomiting during the first 6 hours after surgery.

  4. Preoperative oxidative stress

    Time frame: Immediately before surgery

    Blood chemistry tests for the assessment of preoperative stress

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

    Time frame: Immediate preoperative period

    Evaluation of preoperative stress using the State-Trait Anxiety Inventory - Form Y) in parents of pediatric patients before elective surgery

  6. Evaluation of postoperative oral feeding tolerance

    Time frame: Within 6 hours after surgery

    Oral feeding tolerance will be assessed by the ability to tolerate the first oral intake without vomiting or need to interrupt feeding.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Center

CONTACT

[email protected]

0131206893

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: ERAS-MALTO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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