Ambulatory Surgical Procedures, Pediatric Anesthesia, Postoperative Nausea and Vomiting (PONV)
Conditions
Keywords
Perioperative fasting, Ambulatory surgery, Pediatric postoperative care, Clear fluid intake, Postoperative nausea and vomiting (PONV), Pediatric anesthesia
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.
Interventions
BEHAVIORALEarly Oral Fluid Intake
Participants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia.
BEHAVIORALTraditional Oral Fluid Intake
Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Only the outcomes assessor (the nurse responsible for evaluating postoperative vomiting) is blinded to the group assignments. No other study personnel, caregivers, or participants are masked in this trial.
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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Early Oral Clear Fluid Intake in Children | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Volume of Oral Fluids Tolerated | 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. |
| Incidence of Postoperative Vomiting | 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. |
| Incidence of Postoperative Vomiting on Day 1 and Day 3 | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORFeyza Sever, Assoc Prof
Ankara City Hospital Bilkent
Outcome results
None listed