Early Oral Fluid Intake in Children After Day Surgery

NCT06937684 | Completed

• 1 other identifier: E2-24-6970
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the safety and tolerability of early oral clear fluid intake in children aged 1-8 years undergoing elective outpatient non-gastrointestinal surgeries. Patients will be randomized to receive clear fluids either at 1 hour or 2 hours after general anesthesia. The goal is to determine whether earlier fluid intake increases the risk of postoperative vomiting (POV), or whether it can be safely tolerated in pediatric patients."

Conditions

Pediatric Anesthesia; Postoperative Nausea and Vomiting (PONV); Ambulatory Surgical Procedures

Keywords

Perioperative fasting; Ambulatory surgery; Pediatric postoperative care; Clear fluid intake; Postoperative nausea and vomiting (PONV); Pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• Tolerability of Early Oral Clear Fluid Intake in Children

  The number of pediatric participants who are able to tolerate clear oral fluids (up to 10 ml/kg) administered 1 hour after general anesthesia without experiencing vomiting, desaturation (SpO₂ \< 94%), or other adverse events. Tolerability is defined as successful ingestion of the planned fluid volume without signs of intolerance such as nausea, vomiting, or clinical deterioration.

  From end of anesthesia to discharge (approximately 3-4 hours postoperative)

Secondary Outcomes (3)

• Total Volume of Oral Fluids Tolerated

  Within 1 and 2 hours post-anesthesia

• Incidence of Postoperative Vomiting

  From end of anesthesia to discharge (within approximately 4 hours)

• Incidence of Postoperative Vomiting on Day 1 and Day 3

  Postoperative day 1 and day 3

Study Arms (2)

Early Oral Intake Group (Group E)

EXPERIMENTAL

Patients in this group will receive a maximum of 10 ml/kg of clear fluids (e.g., water or clear fruit juice) starting at 1 hour after the completion of general anesthesia.

Behavioral: Early Oral Fluid Intake

Traditional Oral Intake Group (Group T)

ACTIVE COMPARATOR

Patients in this group will receive a maximum of 10 ml/kg of clear fluids (e.g., water or clear fruit juice) starting at 2 hours after the completion of general anesthesia.

Behavioral: Traditional Oral Fluid Intake

Interventions

Early Oral Fluid Intake BEHAVIORAL

Participants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia.

Early Oral Intake Group (Group E)

Traditional Oral Fluid Intake BEHAVIORAL

Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.

Traditional Oral Intake Group (Group T)

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 1 and 8 years
• ASA Physical Status I or II
• Undergoing elective, outpatient, non-gastrointestinal surgery under general anesthesia
• Expected to be discharged on the same day
• Parent/guardian provides informed consent

You may not qualify if:

• Emergency surgeries
• History of gastrointestinal disorders
• History of aspiration or recurrent vomiting
• Children with neurodevelopmental delay
• Intraoperative complications requiring ICU admission
• Refusal of oral intake postoperatively

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Feyza Sever, Assoc Prof

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcomes assessor (the nurse responsible for evaluating postoperative vomiting) is blinded to the group assignments. No other study personnel, caregivers, or participants are masked in this trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, parallel-group, randomized controlled trial. Participants will be randomly assigned to one of two groups to receive a maximum of 10 ml/kg of clear fluids either 1 hour (early group) or 2 hours (traditional group) after general anesthesia. Each participant will be assigned to only one group and will receive the intervention once.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)