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Completed

NCT Number: NCT06937684

Early Oral Fluid Intake in Children After Day Surgery

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."

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Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital Bilkent

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Oral Fluid Intake

Behavioral

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

Traditional Oral Fluid Intake

Behavioral

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

Primary outcomes

  1. Tolerability of Early Oral Clear Fluid Intake in Children

    Time frame: 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 outcomes

  1. Total Volume of Oral Fluids Tolerated

    Time frame: 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.

  2. Incidence of Postoperative Vomiting

    Time frame: 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.

  3. Incidence of Postoperative Vomiting on Day 1 and Day 3

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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