Early Oral Fluid Intake in Children After Day Surgery

Ankara City Hospital

Status: Enrolling

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

Treatments: Behavioral: Traditional Oral Fluid Intake; Behavioral: Early Oral Fluid Intake

Study type: Interventional

Funder types: Other

Identifiers

NCT06937684

E2-24-6970

Details and patient eligibility

About

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."

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Early Oral Intake Group (Group E)

Experimental group

Description:

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.

Treatment:

Behavioral: Early Oral Fluid Intake

Traditional Oral Intake Group (Group T)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Traditional Oral Fluid Intake