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

Not yet recruiting

Conditions

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

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

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
İn Children Aged 2-8 Years Undergoing Elective Urogenital Surgery:

What is the study measuring?

Primary Outcome Measures

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

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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