An interventional study of Maltodextrin Clear Liquid and Non-Sugared Clear Liquid in Preoperative Care, Anxiety and Pediatric Surgery, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Recruiting at 1 site in Italy. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Not applicable, Interventional, and Supportive care
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.
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.
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's planned enrollment of 200 is above the median of 45 across 311 interventional studies indexed under Fasting.
Browse Fasting studies →Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.
Compared within Fasting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
Time frame: 20 to 30 minutes before 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.
Time frame: 2 hours after 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.
Time frame: 6 hours after surgery
Evaluation of postoperative vomiting
Incidence of participants experiencing at least one episode of postoperative vomiting during the first 6 hours after surgery.
Time frame: Within 6 hours after surgery
Preoperative oxidative stress
Blood chemistry tests for the assessment of preoperative stress
Time frame: Immediately before surgery
Preoperative stress assessed by State-Trait Anxiety Inventory - Form Y (STAI-Y)
Evaluation of preoperative stress using the State-Trait Anxiety Inventory - Form Y) in parents of pediatric patients before elective surgery
Time frame: Immediate preoperative period
Evaluation of postoperative oral feeding tolerance
Oral feeding tolerance will be assessed by the ability to tolerate the first oral intake without vomiting or need to interrupt feeding.
Time frame: Within 6 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2027, 20 months after the start.
Of 144 non-industry interventional studies with no phase under Fasting, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 40. This study's planned 20 months is close to that.
Counting every sponsor, half of 149 studies reached it within 18 months; a quarter within 6 and three quarters within 40.
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Studies of the drug tested here: Maltodextrin
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria