Набор скоро начнётся NCT07435493

Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea

Без фазы С лечением Adenotonsillectomy Obstructive Sleep Apnea (OSA) Fentanyl Opioid

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: В протоколе указаны: Group A: Fentanyl-Based Analgesia, Group B: Opioid-Free Multimodal Analgesia.
Кому может быть актуально: Состояния в реестре: Adenotonsillectomy, Obstructive Sleep Apnea (OSA), Fentanyl, Opioid. Базовые параметры: 5 лет — 10 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: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate Obstructive Sleep Apnea undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.

Подробное описание

Obstructive Sleep Apnea in pediatrics is a sleep disorder characterized by repeated episodes of partial or complete upper airway obstruction during sleep, leading to disrupted breathing, poor sleep quality, and potential developmental and health issues.

Since adeno-tonsillar hypertrophy and enlarged tonsils \& adenoids are the most common causes of pediatric Obstructive Sleep Apnea ,thus adenotonsillectomy is the first-line surgical treatment and is one of the most common pediatric surgeries that has a high success rate in resolving Obstructive Sleep Apnea symptoms with cure rate up to 80%.

Adenotonsillectomy is a common surgical procedure in pediatric patients and perioperative pain management with opioids is common and associated with side effects and risks. Consequently, analgesic strategies to reduce opioid utilization have been developed, because Obstructive Sleep Apnea patients are more sensitive to opioids.

Fentanyl has demonstrated efficacy in pediatrics for acute pain management but still has the risk of opioids induced ventilatory impairment which is very common in children with obstructive sleep apnea due to altered volume of distribution and clearance.

A multimodal analgesia approach, which combines various non-opioid medications (acetaminophen, non-steroidal anti-inflammatory drugs, dexamethasone and ketamine ) can effectively manage perioperative pain in children with mild to moderate Obstructive Sleep Apnea with (apnea hypoxia index \<or= 10) undergoing adenotonsillectomy, while minimizing the risks associated with opioid use.

The purpose of this study is to emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate OSA undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.

Вмешательства

Препарат Group A: Fentanyl-Based Analgesia
Fentanyl-Based Analgesia will receive intraoperative fentanyl (1 μg/kg IV) with standard anesthetic care with postoperative rescue analgesia with acetaminophen (15 mg/kg) as needed
Препарат Group B: Opioid-Free Multimodal Analgesia
Opioid-Free Multimodal Analgesia will receive preoperative acetaminophen (15 mg/kg) and ibuprofen (10 mg/kg), intraoperative ketamine (0.5 mg/kg IV) and dexamethasone (0.1 mg/kg IV) with postoperative rescue analgesia with acetaminophen as needed.

Первичные конечные точки

FLACC Scale (face, legs, activity, cry, consolability) [Срок оценки: at 0 hours, 2hours, and 6 hours postoperatively]

Вторичные конечные точки (1)

Time to oral intake [Срок оценки: 6 hours postoperatively]

Критерии участия

Критерии включения

Children aged 5-10 years.
Diagnosed with mild to moderate Obstructive Sleep Apnea (apnea-hypoxia index 1-10).
Scheduled for elective adenotonsillectomy.
American Society of Anesthesiologists physical status I-II.