Pediatric AnesthesiaNCT06937684
Early Oral Fluid Intake in Children After Day Surgery
A study testing Early Oral Fluid Intake and Traditional Oral Fluid Intake in people with Pediatric Anesthesia and Postoperative Nausea and Vomiting (PONV), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Anesthesia, Postoperative Nausea and Vomiting (PONV), Ambulatory Surgical Procedures
- What is being tested?
- Early Oral Fluid Intake and Traditional Oral Fluid Intake
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Oral Fluid Timing and Volume in Children Aged 1-8 Following Ambulatory Surgery: A Prospective Randomized Controlled Trial
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."
Read the 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.
- Conditions
- Pediatric Anesthesia, Postoperative Nausea and Vomiting (PONV), Ambulatory Surgical Procedures
- Being tested
- Early Oral Fluid Intake, Traditional Oral Fluid Intake
- Keywords
- Perioperative fasting, Ambulatory surgery, Pediatric postoperative care, Clear fluid intake, Postoperative nausea and vomiting (PONV), Pediatric anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Oral Fluid IntakeBehavioural
Participants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia.
Traditional Oral Fluid IntakeBehavioural
Participants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Early Oral Intake Group (Group E) | Experimental | 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. Receives: Behavioral: Early Oral Fluid Intake |
| Traditional Oral Intake Group (Group T) | Active comparator | 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. Receives: Behavioral: Traditional Oral Fluid Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From end of anesthesia to discharge (approximately 3-4 hours postoperative)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Postoperative day 1 and day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feyza Sever, Assoc Prof, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937684
- Sponsor's protocol ID
- E2-24-6970
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Fluid Timing and Volume in Children Aged 1-8 Following Ambulatory Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06937684
- Acronym / sponsor ID
- E2-24-6970
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Oral Intake Group (Group E) | Experimental | Behavioral: Early Oral Fluid IntakePatients 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. |
| Traditional Oral Intake Group (Group T) | Active comparator | Behavioral: Traditional Oral Fluid IntakePatients 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. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Emergency surgeries
- History of gastrointestinal disorders
- History of aspiration or recurrent vomiting
- Children with neurodevelopmental delay
- Intraoperative complications requiring ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Oral Fluid IntakeParticipants receive clear fluids up to 10 ml/kg at 1 hour after anesthesia. | Behavioural | Early Oral Intake Group (Group E) |
| Traditional Oral Fluid IntakeParticipants receive clear fluids up to 10 ml/kg at 2 hours after anesthesia. | Behavioural | Traditional Oral Intake Group (Group T) |
Primary outcome
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.
3 secondary outcomes
Total Volume of Oral Fluids Tolerated
Time frame: Within 1 and 2 hours post-anesthesia
Incidence of Postoperative Vomiting
Time frame: From end of anesthesia to discharge (within approximately 4 hours)
Incidence of Postoperative Vomiting on Day 1 and Day 3
Time frame: Postoperative day 1 and day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pediatric Anesthesia
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feyza Sever, Assoc Prof principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Oral Fluid Intake and Traditional Oral Fluid Intake in people with Pediatric Anesthesia and Postoperative Nausea and Vomiting (PONV), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Early Oral Clear Fluid Intake in Children (time frame: From end of anesthesia to discharge (approximately 3-4 hours postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.