Набор скоро начнётся NCT07604337

Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia

Без фазы С лечением Emergence Delirium Pediatric Dental General Anesthesia Postoperative Recovery

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: Pre-emptive Local Anesthesia, Articaine Hydrochloride With Epinephrine.
Кому может быть актуально: Состояния в реестре: Emergence Delirium, Pediatric Dental General Anesthesia, Postoperative Recovery. Базовые параметры: 7 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: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Pre-emptive Local Anesthesia on Emergence Behavior and Early Recovery Quality After Ambulatory Pediatric Dental General Anesthesia: A Parallel-Group Randomized Controlled Trial

Обзор

This study will evaluate whether pre-emptive local anesthesia improves early recovery after ambulatory pediatric dental general anesthesia. Children aged 7-12 years scheduled for dental treatment under general anesthesia will be randomly assigned to receive either pre-emptive local anesthesia or no local anesthesia. Emergence delirium, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal Pediatric Anesthesia Emergence Delirium Scale score during the first 30 minutes in the post-anesthesia care unit.

Подробное описание

This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial in children aged 7-12 years undergoing ambulatory dental treatment under general anesthesia.

Participants will be randomized in a 1:1 ratio to one of two groups: pre-emptive local anesthesia or no local anesthesia. In the pre-emptive local anesthesia group, local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. In the no local anesthesia group, local anesthesia will not be routinely administered. If clinically required, rescue analgesia or additional local anesthesia may be administered at the discretion of the responsible clinician and will be recorded.

Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale. In the post-anesthesia care unit, sedation and arousal will be assessed using the Richmond Agitation-Sedation Scale before each emergence delirium and pain assessment. Emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale at 0, 5, 10, 15, and 30 minutes after arrival in the post-anesthesia care unit, only when the child meets predefined arousal criteria. Pain will be assessed using the Faces Pain Scale-Revised at the same time points. Recovery quality before discharge will be assessed using the QoR-15 Pictorial form.

The study aims to determine whether reducing peri-emergence nociceptive input with pre-emptive local anesthesia improves emergence delirium severity, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.

Вмешательства

Процедура Pre-emptive Local Anesthesia
Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.
Препарат Articaine Hydrochloride With Epinephrine
Articaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group. The total volume, total dose, dose per kilogram, and injection sites will be recorded.

Первичные конечные точки

Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery [Срок оценки: PACU minutes 0, 5, 10, 15, and 30]

Вторичные конечные точки (2)

Postoperative Pain Score [Срок оценки: PACU minutes 0, 5, 10, 15, and 30]
Recovery Quality Before Discharge [Срок оценки: Before discharge on day of surgery]

Критерии участия

Критерии включения

Children aged 7 to 12 years
ASA physical status I or II
Scheduled for ambulatory dental treatment under general anesthesia
Ability to understand and respond to age-appropriate pain and recovery assessment tools
Written informed consent obtained from a parent or legal guardian
Child assent obtained when appropriate