Anxiety, Pediatric Surgery, Preoperative Care
Conditions
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
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMaltodextrin 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.
OTHERNon-Sugared Clear Liquid
Administration of 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective pediatric surgery.
Sponsors
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
None (Open Label)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative anxiety measured by Modified Yale Preoperative Anxiety Scale (m-YPAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain assessed by Visual Analogue Scale (VAS) | 2 hours after surgery | Evaluation of postoperative pain using the Visual Analogue Scale (VAS) in pediatric patients after elective surgery. |
| Eligibility for discharge after surgery | 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. |
| Evaluation of postoperative vomiting | Within 6 hours after surgery | Incidence of participants experiencing at least one episode of postoperative vomiting during the first 6 hours after surgery. |
| Preoperative oxidative stress | Immediately before surgery | Blood chemistry tests for the assessment of preoperative stress |
| Preoperative stress assessed by State-Trait Anxiety Inventory - Form Y (STAI-Y) | Immediate preoperative period | Evaluation of preoperative stress using the State-Trait Anxiety Inventory - Form Y) in parents of pediatric patients before elective surgery |
| Evaluation of postoperative oral feeding tolerance | 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. |
Countries
Italy
Contacts
CONTACTClinical Trial Center
Outcome results
None listed