Effect of Preoperative Fasting Duration on Postoperative Pain and Emergence Agitation in Pediatric Patients Undergoing Urogenital Surgery

April 30, 2026 updated by: Gamze Talih, TC Erciyes University

The Impact of Preoperative Fasting Duration on Postoperative Pain and Emergence Agitation in Children Aged 2-8 Years Undergoing Elective Urogenital Surgery: A Prospective Observational Cohort Study

This study aims to evaluate the effect of preoperative fasting duration on postoperative pain and emergence agitation in pediatric patients undergoing urogenital surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The primary purpose of preoperative fasting is to reduce the risk of aspiration during general anesthesia. During anesthesia induction, loss of consciousness and suppression of reflexes can lead to regurgitation of gastric contents. If this content is aspirated, aspiration pneumonia (Mendelson syndrome) can develop. This is a complication that can lead to serious morbidity and mortality. Therefore, preoperative fasting is implemented to ensure gastric emptying. The ideal preoperative fasting period has been determined. It is approximately 1-2 hours for liquids, 2-4 hours for breast milk and formula, and 6-8 hours for solid foods.However, changes in the order of cases in the operating room, unexpected extensions in surgical time, planning errors, and technical malfunctions can prolong the preoperative waiting time and consequently the fasting period for patients. Children have a faster metabolism, and prolonged fasting can lead to hypoglycemia, dehydration, restlessness, increased stress, and suppression of the immune response.Preoperative fasting time can affect postoperative nausea and vomiting, increased inflammatory response, and postoperative pain. Shortening the preoperative fasting period has been shown to reduce postoperative pain scores in children undergoing adenotonsillectomy.Delirium/agitation occurs during recovery from anesthesia and can be seen in 10% to 80% of children after exposure to inhalation anesthetics. This phenomenon is characterized by screaming, thrashing, kicking, and aimless restlessness. This can cause dissatisfaction among parents and lead to self-harm and harm to others. Predisposing factors include inhalation anesthesia (sevoflurane), preoperative anxiety, rapid induction, male gender, parental anxiety, and specific surgical procedures.Although the mechanism of emergent delirium (recovery agitation) is not entirely clear, some pharmacological agents such as propofol, benzodiazepines, or α2 agonists have been used to prevent and treat this complication. However, due to the occurrence of side effects such as respiratory depression and bradycardia, research has focused on preventing delirium rather than treating it. Urogenital surgery is one of the most frequently performed surgeries in children. No studies investigating the effect of fasting duration on postoperative pain and emergent delirium in these patients have been found in the literature. Our main hypothesis in this study was that increasing fasting duration would increase pain and delirium in this patient group. Correct fasting durations improve preoperative and postoperative comfort and reduce anxiety in children and parents. It also increases patient safety.Hospital. The study will include 250 pediatric patients aged 2-8 years, ASA I-II, undergoing elective urogenital surgery. Patients will be questioned preoperatively (both the patient and their guardian), and their preoperative fasting times will be recorded. The times of their last solid and liquid food intake will also be recorded. Patients will be monitored in the operating room using standard procedures (ECG, SpO₂, NIBP, EtCO₂). Anesthesia induction and maintenance will be performed using standard protocols, and all procedures will be recorded. The postoperative analgesia protocol will be questioned and recorded. Postoperative pain level will be measured using the FLACC (F: Face - L: Legs - A: Activity - C: Cry - C: Consolability) pain scale, and scores will be recorded at 0, 10, 20, and 30 minutes in the postoperative recovery unit. The PAED (Pediatric Anesthesia Emergence Delirium) scale will be used for delirium/agitation. Patient scores will be recorded at 0, 10, 20, and 30 minutes. Any additional analgesics administered will also be recorded. Data will be analyzed using SPSS software. Categorical data will be evaluated using the Chi-square test. The relationship between fasting time and pain and delirium scores will be evaluated using regression analysis. A p-value < 0.05 will be considered statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Kayseri, Turkey (Türkiye)
        • Erciyes University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of pediatric patients aged 2-8 years with ASA physical status I-II undergoing elective urogenital surgery at a single tertiary care university hospital. Eligible participants will be consecutively recruited and assessed preoperatively together with their parents or legal guardians.

Description

Inclusion Criteria:

  • Age between 2 and 8 years
  • ASA physical status I-II
  • Scheduled for elective urogenital surgery

Exclusion Criteria:

  • ASA physical status ≥ III
  • Malnutrition
  • Neuropsychiatric disorders
  • Respiratory tract infection
  • Developmental delay
  • Surgery longer than 2 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
İn Children Aged 2-8 Years Undergoing Elective Urogenital Surgery:

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale in the post-anesthesia care unit
Time Frame: One day

Each item is scored from 0 to 4.

Items 1-3 (Positive behaviors - reverse scored):

The child makes eye contact with the caregiver The child's actions are purposeful The child is aware of his/her surroundings 4 = Not at all 3 = Just a little 2 = Quite a bit

1 = Very much 0 = Extremely

Items 4-5 (Negative behaviors):

The child is restless The child is inconsolable 0 = Not at all

  1. = Just a little
  2. = Quite a bit
  3. = Very much

  4. = Extremely Total Score Range: 0-20 Interpretation

    • 10 → Suggestive of emergence delirium
    • 12 → Strongly indicative / more severe delirium
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Publications and helpful links

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General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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