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Набор скоро начнётся NCT07733622

Effects of Topical Anesthetics on Pain and Anxiety in Children

— Наблюдательное Dental Anxiety Children

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: Dental Anxiety, Children. Базовые параметры: 6 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
Список центров уточняется — проверьте первичный протокол.
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

Evaluation of the Effects of Different Topical Anesthetic Agents on Pain and Anxiety in Pediatric Patients

Обзор

Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited. This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes. Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.

Первичные конечные точки

  • Dental Anxiety Score (MCDASf) [Срок оценки: Baseline (T0) and immediately after local anesthetic administration (T2)]
  • Pain During Local Anesthetic Administration [Срок оценки: Immediately after local anesthetic administration (T2)]
  • Behavioral Response During Local Anesthetic Administration [Срок оценки: During local anesthetic administration (T1)]
Вторичные конечные точки (4)
  • Heart Rate [Срок оценки: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]
  • Blood Pressure [Срок оценки: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]
  • Peripheral Oxygen Saturation (SpO₂) [Срок оценки: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]
  • Body Temperature [Срок оценки: Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2)]

Критерии участия

Критерии включения

  • Children aged 6 to 8 years.
  • Frankl Behavior Rating Scale score of 3 or 4.
  • No previous history of local anesthetic injection for dental treatment.
  • Requiring maxillary infiltration anesthesia for treatment of a maxillary second primary molar.
  • Requiring non-emergency, painless dental treatment.
  • Medically healthy children with no chronic systemic disease, mental disability, or physical disability.
  • Written informed consent obtained from a parent or legal guardian.

Критерии исключения

  • Frankl Behavior Rating Scale score of 1 or 2.
  • Physical or intellectual disability.
  • History of cardiovascular disease, diabetes mellitus, Graves' disease, epilepsy, hyperthyroidism, active infection, phenylketonuria, cardiovascular shock, otorrhea, or otitis.
  • Known hypersensitivity or allergy to benzocaine, lidocaine, or any component of the topical anesthetic formulations.
  • Emergency dental treatment or presence of dental pain requiring urgent intervention.
  • Chronic liver or kidney disease.
  • History of methemoglobinemia.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07733622 · 2026/300

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗