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Набор скоро начнётся NCT07435077

Examining Analgesic Synergy and Efficacy in Trauma Care

Фаза IV С лечением Opioid Use Disorder

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: Buprenorphine, Oxycodone.
Кому может быть актуально
Состояния в реестре: Opioid Use Disorder. Базовые параметры: 18 лет — 80 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
США
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

Examining Analgesic Synergy and Efficacy in Trauma Care-A Randomized, Control Study of Buprenorphine Versus Oxycodone in Multimodal Pain Control Regimens

Обзор

Traumatic injury is responsible for over 25 million (16%) Emergency Department visits and over 225,000 deaths each year per 2021 Center for Disease Control data. This is the 3rd leading cause of death in the US. Often, acute care for the injured patient requires administration of pain medication for the purposes of acute pain control from injury. The mainstay of treatment for pain control has historically involved opioid pain medication.

Подробное описание

A different medication which has been used in place of full agonist opioids is a product known as buprenorphine, which was developed in the 1960's. This medication works as a partial agonist/antagonist of the µ opioid pain receptors. It has performed robustly in comparison to full opioid agonist (FAO) medications, and in a recent meta-analysis of this medication, it was responsible for reducing pain, less rescue analgesia use, and similar rates of adverse events in comparison to full opioid agonist therapy. This also concurrently lowered the amount of Morphine Milligram Equivalents (MME) used by the postoperative patients, although the achievement of lower pain scores is the significant finding. These data assert that buprenorphine is more efficacious than FAO in mitigating acute post op pain due to comparable analgesic effect and longer duration of action when compared to many other oral opioids.

This medication has been commonly used in patients with opioid abuse disorder and has shown improvements in specific patient outcome metrics when induction therapy is performed in hospital for patients with opioid use disorder (OUD). Further, continuation of buprenorphine for patients taking the medication as an outpatient for acute pain control has been shown to be safe, and to have similar efficacy to discontinuation in favor of standard pain regimen therapy.

Вмешательства

  • Препарат Buprenorphine
    2 mg every 6 hours prn for moderate to severe pain If after 2 doses this is insufficient, switch to 4 mg Q6 hours as needed IV buprenorphine 150 mcg Q6 hours for breakthrough pain
  • Препарат Oxycodone
    1000 mg acetaminophen every 6 hours (unless \<60 kg = 15 mg/kg Q6 hours) IV ketorolac 15 mg Q6 hours x 48 hours; Celebrex 200 mg twice a day after 500 mg methocarbamol three times a day If fail conservative study regimens after 24 hours, may switch to a PCA or consider other analgesic regimens (ketamine, epidural, etcetera)

Первичные конечные точки

  • The Numeric Rating Scale (NRS) Pain Scores [Срок оценки: Day 14]
Вторичные конечные точки (5)
  • Morphine equivalent measure (MME) [Срок оценки: Day 14]
  • Number of doses of rescue narcotic [Срок оценки: Day 14]
  • Length of hospital stay [Срок оценки: Day 14]
  • Length of Intensive Care Unit stay length of Intensive Care Unit stay [Срок оценки: Day 14]
  • Opiate prescription utilization post hospitalization (as MME) [Срок оценки: Day 14]

Критерии участия

Критерии включения

  • Adult patients with injury to at least 2 body locations as defined by Abbreviated Injury Scale (AIS) scores (Head, Face, Neck, Chest, Abdomen/Pelvis, Spine, Upper Extremity, Lower Extremity, External)

Критерии исключения

  • Glasgow Coma Scale (GCS) <15 - Patients may be included if their GCS improves to 15 within 24 hours of admission
  • Age <18 years
  • Age ≥80years
  • Prisoners
  • Pregnant patients
  • Non-English speakers
  • Inability to provide consent
  • Home buprenorphine or methadone use
  • Home opioid use >45 Morphine Milligram Equivalents (MME)/day
  • Allergy to any medication within the study or control arm
  • Patients undergoing treatment for alcohol withdrawal
  • History of cirrhosis requiring dose adjustment of Tylenol

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT07435077 · IRB00140421

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗