Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery
NCT07686029 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-07-06
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
Interventions
- DIETARY_SUPPLEMENT
-
Maltodextrin 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.
- OTHER
-
Non-Sugared Clear Liquid
Administration of 125 mL of a non-sugared clear liquid (water, tea, or chamomile) two hours before elective pediatric surgery.
Sponsors & Collaborators
-
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-03
- Primary Completion
- 2027-05-31
- Completion
- 2027-06-30
Countries
- Italy
Study Locations
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