NCT06937684

Early Oral Fluid Intake in Children After Day Surgery

Oral Fluid Timing and Volume in Children Aged 1-8 Following Ambulatory Surgery: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 1 Year – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Early Oral Fluid Intake	Participants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia.
BEHAVIORAL	Traditional Oral Fluid Intake	Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-04-22
• Last updated: 2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)