Меню
Набор скоро начнётся NCT07552259

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

Наблюдательное Postoperative Pain Emergence Delirium Emergence Agitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Postoperative Pain, Emergence Delirium, Emergence Agitation. Базовые параметры: 2 лет — 8 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

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.

Первичные конечные точки

  • Postoperative agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale in the post-anesthesia care unit [Срок оценки: One day]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Erciyes University Faculty of Medicine — Kayseri

Публикации

  • Thomas M, Morrison C, Newton R, Schindler E. Consensus statement on clear fluids fasting for elective pediatric general anesthesia. Paediatr Anaesth. 2018 May;28(5):411-414. doi: 10.1111/pan.13370. Epub 2018 Apr 27. PMID 29700894
  • Dabke T, Scott TE, Taylor B. Impact of preoperative fasting duration on perioperative complications in elective paediatric procedures: a systematic review and meta-analysis. Br J Anaesth. 2026 Jan;136(1):158-166. doi: 10.1016/j.bja.2025.10.037. Epub 2025 Nov 27. PMID 41314944
  • Andersson H, Schmitz A, Frykholm P. Preoperative fasting guidelines in pediatric anesthesia: are we ready for a change? Curr Opin Anaesthesiol. 2018 Jun;31(3):342-348. doi: 10.1097/ACO.0000000000000582. PMID 29443724
  • Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):3 PMID 28045707

Идентификаторы

NCT: NCT07552259 · 2025/601

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗