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Идёт набор NCT07314450

Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department

— Наблюдательное Pain, Procedural Analgesia Extremity Injury Patient Satisfaction

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: Usual Care.
Кому может быть актуально
Состояния в реестре: Pain, Procedural, Analgesia, Extremity Injury, Patient Satisfaction. Базовые параметры: от 18 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department. The main questions it aims to answer are: * Which sedation and analgesia methods provide the best patient satisfaction and pain relief? * How do different treatment methods affect clinician satisfaction and the occurrence of adverse events? The investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation/analgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control. Participants will: Be adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures. Receive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care. Report their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.

Подробное описание

Please refer to the full protocol.

Вмешательства

  • Препарат Usual Care
    No intervention: Patients will receive usual care

Первичные конечные точки

  • Patient satisfaction via Numerical Rating Scale [Срок оценки: Immediately after the procedure]
Вторичные конечные точки (4)
  • Re-call of maximum pain intensity [Срок оценки: Immediately after the procedure]
  • Patient satisfaction via Short Assessment of Patient Satisfaction [Срок оценки: Immediately after the procedure]
  • Clinician satisfaction with analgosedation regimen [Срок оценки: Immediately after the procedure]
  • Incidence of adverse events [Срок оценки: During and immediately after the procedure]

Критерии участия

Критерии включения

  • Age ≥18.
  • Patients with the following injuries are eligible:
  • Reduction treatment of shoulder dislocation
  • Reduction treatment of elbow dislocation
  • Reduction treatment of distal radius fractures, application of cast
  • Reduction treatment of finger fractures/dislocation
  • Casting treatment of upper extremity fractures
  • Proximal humerus fracture, application of fixed sling
  • Humeral shaft fracture, application of Sarmiento brace
  • Supracondylar fracture, application of angled cast
  • Reduction treatment of hip dislocation
  • Reduction treatment of patella dislocation
  • Reduction of tibial shaft fracture, application of cast
  • Reduction treatment of ankle fractures including distal tibia fracture
  • Reduction treatment for toe fractures/dislocation
  • Casting treatment of lower extremity fractures
  • Distal femur fracture, application of cast/traction
  • Proximal tibia fracture, application of cast or hinged brace
  • Ankle fracture, application of walker

Критерии исключения

  • Unable to give informed consent (e.g. unconscious, psychotic or dementia)
  • Unwilling to participate in the study
  • Prior inclusion in the study
  • Already included in another clinical study at the same day/hospital visit
  • Pregnant or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 3 центра
  • Emergency Department, Holbæk Hospital — Holbæk
  • Emergency Department, Zealand University Hospital — Køge
  • Emergency Department, Odense University Hospital — Odense

Идентификаторы

NCT: NCT07314450 · p-2025-19278 · S-20252000-95

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗