Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
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: Intravenous (IV) acetaminophen + oral placebo, Intravenous (IV) placebo plus oral acetaminophen.
- Кому может быть актуально
- Состояния в реестре: Hip-fracture, Surgery. Базовые параметры: от 60 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
- Канада
- 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
INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
Обзор
The INTACT-HIP trial study will evaluate feasibility of conducting a randomized, double-blinded controlled trial comparing postoperative treatment with intravenous (IV) acetaminophen versus oral acetaminophen, in older adults undergoing hip fracture surgery. The results of this feasibility trial will be used to inform designing a larger, multi-center, randomized controlled trial to assess the efficacy of IV acetaminophen compared to oral acetaminophen to reduce delirium and improve other clinical and patient-centered outcomes after hip fracture surgery. It will randomize 42 older adults to receive either oral or IV acetaminophen after hip fracture surgery.
Вмешательства
- Препарат Intravenous (IV) acetaminophen + oral placebo
Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet. - Препарат Intravenous (IV) placebo plus oral acetaminophen
Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group the IV study drug will be normal saline and the pill will be acetaminophen
Первичные конечные точки
- Trial feasibility-Recruitment [Срок оценки: 30 days]
- Trial feasibility-Attrition [Срок оценки: 30 days]
- Trial feasibility-Availability of human resources [Срок оценки: 30 days]
- Trial feasibility-Comply study procedures [Срок оценки: 30 days]
- Trial safety [Срок оценки: 30 days]
Вторичные конечные точки (9)
- Postoperative pain [Срок оценки: Before surgery, on day of surgery, and days 1,2,3 after surgery]
- Opioid consumption [Срок оценки: Before surgery, on day of surgery, and days 1,2,3 after surgery]
- Delirium [Срок оценки: On day of surgery, and days 1,2, 3 after surgery]
- Cognitive dysfunction [Срок оценки: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)]
- Overall health and disability [Срок оценки: Baseline and at 30 days after surgery]
- Depression screen [Срок оценки: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)]
- Ambulation [Срок оценки: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)]
- Post-operative adverse events [Срок оценки: On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery]
- Discharge location [Срок оценки: At the time of discharge (at 1-3 days after surgery in most cases)]
Критерии участия
Критерии включения
- 60 years of age and older
- Patients who were ambulating without human assistance before fracture, with any type of non-neoplastic hip fracture
- Patients undergoing surgical treatment as an inpatient
Критерии исключения
- Patients with neoplastic hip fracture
- Severe cognitive impairment (Montreal Cognitive Assessment (MoCA) <10)
- Pre-existing delirium
- Known hypersensitivity or allergy to acetaminophen
- Severe or chronic liver or kidney dysfunction
- Planned postoperative ventilation
- Swallowing issues and/or dysphagia
- English language limitation
- Weight <50kg
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
Канада · 1 центр
- Toronto Western Hospital (UHN) — Toronto
Публикации
- Jahr JS, Breitmeyer JB, Pan C, Royal MA, Ang RY. Safety and efficacy of intravenous acetaminophen in the elderly after major orthopedic surgery: subset data analysis from 3, randomized, placebo-controlled trials. Am J Ther. 2012 Mar;19(2):66-75. doi: 10.1097/MJT.0b013e3182456810. PMID 22354127
- Chen DX, Yang L, Ding L, Li SY, Qi YN, Li Q. Perioperative outcomes in geriatric patients undergoing hip fracture surgery with different anesthesia techniques: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18220. doi: 10.1097/MD.0000000000018220. PMID 31804347
- Harris MJ, Brovman EY, Urman RD. Clinical predictors of postoperative delirium, functional status, and mortality in geriatric patients undergoing non-elective surgery for hip fracture. J Clin Anesth. 2019 Dec;58:61-71. doi: 10.1016/j.jclinane.2019.05.010. Epub 2019 May 14. PMID 31100691
Идентификаторы
NCT: NCT05425355 · 21-5733