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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Placebo Comparator | Pediatric patients receiving 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain assessed by Visual Analogue Scale (VAS) | Evaluation of postoperative pain using the Visual Analogue Scale (VAS) in pediatric patients after elective surgery. | 2 hours after surgery |
| Eligibility for discharge after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Center | Contact | 0131206893 | clinicaltrialcenter@ospedale.al.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo | Recruiting | Alessandria | Piedmont | 15121 | Italy |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D005215 | Fasting |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D000070601 | Diet, Carbohydrate Loading |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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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.
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None (Open Label)
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|
| 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. |
|
|
Evaluation of the proportion of pediatric patients considered eligible for discharge 6 hours after elective surgery according to postoperative recovery and clinical conditions.
| 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. | Within 6 hours after surgery |
| Preoperative oxidative stress | Blood chemistry tests for the assessment of preoperative stress | 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 | 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. | Within 6 hours after surgery |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |