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NCT Number: NCT07552259

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    • = Just a little
    • = Quite a bit
    • = Very much
    • = Extremely Total Score Range: 0-20 Interpretation
    • 10 → Suggestive of emergence delirium
    • 12 → Strongly indicative / more severe delirium

Study contacts

Contact information is provided by the study sponsor or research team.

GAMZE TALIH, MD

CONTACT

[email protected]

+905447604780

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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