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Идёт набор NCT06464146

Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine

Фаза III С лечением Limb Injury

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: Morphine, IN fentanyl, IN ketamine, NaCl 0,9 %.
Кому может быть актуально
Состояния в реестре: Limb Injury. Базовые параметры: 2 лет — 17 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
Франция
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

Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine

Обзор

The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.

Подробное описание

In children with moderate to severe pain due to musculoskeletal injuries, the first-line analgesic therapy in pediatric emergency departments (ED) is oral or intravenous morphine. Due to the delay or discomfort associated with establishing IV access, oral forms are preferred in French ED. Unfortunately, oral morphine alone or with ibuprofen or paracetamol, none regimen is optimal for relieving pain in children with traumatic limb injuries. However, the use of intranasal course is a safe route that can provide rapid and almost immediate analgesia. Intranasal administration is easy, non-invasive and usually well tolerated by children. In the last years, drugs with analgesic and sedative properties is increasing, particularly on fentanyl, ketamine, which can be also administered by the IN route. There are currently no studies, neither published nor ongoing, which compare IN fentanyl or IN ketamine to a standard oral morphine for children with acute moderate to severe pain with limb injuries presenting to the ED. The main hypothesis is that the efficacy of the analgesia 30 minutes after the administration will be higher with IN Fentanyl or with IN Ketamine, when compared to oral morphine.

Вмешательства

  • Препарат Morphine
    oral morphine (0.5 mg / kg)
  • Препарат IN fentanyl
    IN fentanyl (1.5 µg/kg)
  • Препарат IN ketamine
    IN ketamine (1 mg/kg)
  • Препарат NaCl 0,9 %
    Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.

Первичные конечные точки

  • Degree of pain (M30) [Срок оценки: 30 minutes]
  • Degree of pain (M30) [Срок оценки: 30 minutes]
Вторичные конечные точки (12)
  • Degree of pain (M15) [Срок оценки: 15 minutes]
  • Degree of pain (M15) [Срок оценки: 15 minutes]
  • Degree of pain (M60) [Срок оценки: 60 minutes]
  • Degree of pain (M60) [Срок оценки: 60 minutes]
  • Degree of pain (M90) [Срок оценки: 90 minutes]
  • Degree of pain (M90) [Срок оценки: 90 minutes]
  • Degree of pain (M120) [Срок оценки: 120 minutes]
  • Degree of pain (M120) [Срок оценки: 120 minutes]
  • Reduction in pain (M15) [Срок оценки: 15 minutes]
  • Reduction in pain (M15) [Срок оценки: 15 minutes]
  • Reduction in pain (M30) [Срок оценки: 30 minutes]
  • Reduction in pain (M30) [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

  • Child aged 2 years to 17 years and 11 months
  • With 10 kg ≤ Weight ≤ 100 kg
  • Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and/or functional impotence in the injured limb(s)
  • Within the first 12 hours after the injury
  • VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7 years) or Evendol pain score at ED arrival ≥ 7/15 (if child < 7 years)
  • Affiliated to health insurance
  • At least one signed parental informed consent

Критерии исключения

  • Received narcotic pain medication prior to arrival
  • Contraindication to morphine, mentioned in SmPC
  • Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids.
  • Contraindication to fentanyl or ketamine, mentioned in SmPC
  • GCS <15
  • Evidence of significant femur, head, chest, abdominal, or spine injury
  • Open fracture
  • Nasal trauma or complete nasal obstruction
  • Active epistaxis
  • Nasal or sinus surgery within 6 months before inclusion
  • History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, major psychiatric disorder, hepatocellular insufficiency
  • Active or history of psychiatric disorder
  • Known pregnancy or suspicion of being pregnant
  • Breastfeeding
  • Non-French speaking parent and / or child.
  • Participation to another interventional clinical research

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Франция · 5 центров
  • Ambroise Paré Hospital — Boulogne-Billancourt
  • Roger Salengro Hospital — Lille
  • Timone Hospital — Marseille
  • Mère-Enfant Hospital — Nantes
  • Hopital Necker Enfants malades — Paris

Идентификаторы

NCT: NCT06464146 · APHP211044 · 2023-506803-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗