Early Oral Fluid Intake in Children After Day Surgery

Not Applicable

Recruiting

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

• Registration Number: NCT06937684
• Lead Sponsor: Ankara City Hospital Bilkent

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."

Detailed Description

This prospective, randomized controlled clinical trial aims to evaluate the safety and tolerability of early oral clear fluid intake in children aged 1 to 8 years undergoing elective, outpatient, non-gastrointestinal surgery under general anesthesia. Recent guidelines recommend reducing preoperative and postoperative fasting durations in children to enhance recovery and well-being. Early postoperative hydration has been associated with reduced opioid requirements, faster return to normal diet and ambulation, and shorter hospital stay, without increasing the risk of postoperative nausea and vomiting (PONV).

In this study, participants will be randomly assigned to one of two groups. Group E (early group) will receive up to 10 ml/kg of clear fluids (e.g., water, clear juice) one hour after the end of anesthesia, while Group T (traditional group) will receive the same amount two hours after anesthesia. Patients will be evaluated for readiness to drink based on recovery of consciousness, protective airway reflexes, and absence of nausea or vomiting. Fluid will be administered slowly and under strict supervision by experienced staff, with emergency equipment readily available.

The incidence of vomiting will be assessed using a modified 4-point scale. Additional outcome measures include tolerability of oral fluids, time to readiness for discharge, and incidence of delayed postoperative vomiting on postoperative days 1 and 3, assessed via phone interviews with caregivers. This study seeks to provide evidence-based guidance on the optimal timing and volume of clear fluid intake in pediatric patients following ambulatory minor surgical procedures, contributing to more flexible and patient-centered perioperative fasting protocols.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerability of Early Oral Clear Fluid Intake in Children	From end of anesthesia to discharge (approximately 3-4 hours postoperative)	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.

Secondary Outcome Measures

Name	Time	Method
Total Volume of Oral Fluids Tolerated	Within 1 and 2 hours post-anesthesia	Amount of oral clear fluid (in ml/kg) successfully consumed by participants during the initial postoperative oral hydration attempt.
Incidence of Postoperative Vomiting	From end of anesthesia to discharge (within approximately 4 hours)	Number of participants who experience vomiting after receiving oral clear fluids, as assessed using a 4-point modified vomiting scale from anesthesia end until discharge.
Incidence of Postoperative Vomiting on Day 1 and Day 3	Postoperative day 1 and day 3	Number of participants with parent-reported postoperative nausea assessed via structured telephone interviews conducted on postoperative day 1 and day 3.

Trial Locations

Locations (1)

Ankara City Hospital Bilkent; 🇹🇷 Ankara, Turkey