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

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."

Study Overview

• Status: Completed
• Conditions: Pediatric Anesthesia; Ambulatory Surgical Procedures; Postoperative Nausea and Vomiting (PONV)
• Intervention / Treatment: Behavioral: Early Oral Fluid Intake; Behavioral: Traditional Oral Fluid Intake

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara City Hospital Bilkent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Oral Intake Group (Group E); 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; Participants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia.
Active Comparator: Traditional Oral Intake Group (Group T); 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; Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Volume of Oral Fluids Tolerated	Amount of oral clear fluid (in ml/kg) successfully consumed by participants during the initial postoperative oral hydration attempt.	Within 1 and 2 hours post-anesthesia
Incidence of Postoperative Vomiting	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.	From end of anesthesia to discharge (within approximately 4 hours)
Incidence of Postoperative Vomiting on 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.	Postoperative day 1 and day 3

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Feyza Sever, Assoc Prof, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Ambulatory surgery; Postoperative nausea and vomiting (PONV); Pediatric anesthesia; Perioperative fasting; Pediatric postoperative care; Clear fluid intake
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting
• Other Study ID Numbers: E2-24-6970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No