Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.
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: Oral Clonidine (OC).
- Кому может быть актуально
- Состояния в реестре: Pediatric Sedation, Clonidine Sedation, Ketamine Sedation. Базовые параметры: 3 лет — 12 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
Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.
Подробное описание
Surgery and anesthesia induce considerable emotional stress on parents and children. Children are particularly vulnerable to this surgical stress response since their limited energy reserves; larger brain mass, compared to body size; and glucose requirements. Thus, controlling and preventing perioperative stress responses is crucial in modern pediatric anesthesia. Many postoperative negative behavioral changes such as nightmares and separation anxiety. In addition to these behavioral manifestations, preoperative anxiety activates the human stress response. So, a multimodal approach consisting of sedative drugs, parental presence, play therapy, familiar environment and effective pain therapy is necessary to reduce preoperative anxiety. The benzodiazepine midazolam has traditionally been used to relieve preoperative stress and provide sedation in pediatric patients; however, in higher doses, it has an increased risk of respiratory depression.
Alternatively, premedication with clonidine, although less popular, has been shown to reliably produce preoperative sedation and anxiolysis in children; furthermore, it has analgesic properties, decreases volatile anesthetic and opioids requirements and improves perioperative hemodynamic stability.
Clonidine, a selective centrally acting partial a2-agonist, traditionally, it has been used as an antihypertensive agent since the late sixties. Its primary effect is a sympatholytic drug, and it reduces peripheral norepinephrine release by stimulation of the prejunctional inhibitory alpha-2 adrenoceptors. Further uses based on its sedative, anxiolytic and analgesic properties are being developed.
Ketamine is a sedative premedication that is commonly used in children. It is an N-methyl D-aspartate (NMDA) receptor antagonist that produces sedation, immobilization, and analgesia without causing respiratory depression. It has been used in a variety of ways, most recently intranasal in children To the best of our knowledge, no previous studies compared between oral ketamine and oral clonidine as premedication in children undergoing elective lower abdominal day-case surgery.
Вмешательства
- Препарат Oral Clonidine (OC)
compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.
Первичные конечные точки
- Sedation level [Срок оценки: 60 minutes after administration of the drug (at time of separation from the parents).]
Вторичные конечные точки (2)
- Fentanyl administration. [Срок оценки: at 10, 20, 30, 40, 50 minutes until the end of the surgery]
- Postoperative emergence delirium [Срок оценки: Postoperative at 15, 30, 45 and 60 minutes]
Критерии участия
Критерии включения
- Children aged between 3 to 12 years old of both sexes undergoing elective lower abdominal day-case surgery such as: oblique inguinal herniorrhaphy, hypospadias correction and circumcision.
- ASA I and II
Критерии исключения
- Parents refusal.
- ASA risk score >II
- Heart, lung, neurological, or central nervous system disorders (hypotension, hypovolemia, severe bradyarrhythmia, atrioventricular block II or III, acute cerebrovascular events, impaired consciousness, respiratory disorders with hypoventilation, myasthenia gravis and central sleep apnea syndrome)
- Allergy from the used drugs.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Другое
Центры проведения
Египет · 1 центр
- Faculty of Medicine, Cairo University — Cairo
Идентификаторы
NCT: NCT07461376 · Pediatric Sedation