Clinical trial NCT06937684: Early Oral Fluid Intake in Children After Day Surgery
Official title: Oral Fluid Timing and Volume in Children Aged 1-8 Following Ambulatory Surgery: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Anesthesia
Postoperative Nausea and Vomiting (PONV)
Ambulatory Surgical Procedures
Keywords: Perioperative fasting
Ambulatory surgery
Pediatric postoperative care
Clear fluid intake
Postoperative nausea and vomiting (PONV)
Pediatric anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, parallel-group, randomized controlled trial. Participants will be randomly assigned to one of two groups to receive a maximum of 10 ml/kg of clear fluids either 1 hour (early group) or 2 hours (traditional group) after general anesthesia. Each participant will be assigned to only one group and will receive the intervention once.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tolerability of Early Oral Clear Fluid Intake in Children
timeFrame: From end of anesthesia to discharge (approximately 3-4 hours postoperative)
Secondary outcomes:
measure: Total Volume of Oral Fluids Tolerated
timeFrame: Within 1 and 2 hours post-anesthesia
measure: Incidence of Postoperative Vomiting
timeFrame: From end of anesthesia to discharge (within approximately 4 hours)
measure: Incidence of Postoperative Vomiting on Day 1 and Day 3
timeFrame: Postoperative day 1 and day 3
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Feyza Sever, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: