An interventional study of Early Oral Fluid Intake and Traditional Oral Fluid Intake in Pediatric Anesthesia, Postoperative Nausea and Vomiting (PONV) and Ambulatory Surgical Procedures, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Year to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Supportive care
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."
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.
609 studies on the registry are indexed under Postoperative Nausea and Vomiting; 109 are open to participants now.
This study's enrollment of 172 is above the median of 113 across 508 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 1 hour after anesthesia.
Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.
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.
Time frame: From end of anesthesia to discharge (approximately 3-4 hours postoperative)
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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative day 1 and day 3
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Postoperative Nausea and Vomiting→
Ankara City Hospital Bilkent