Набор по приглашению NCT05477004

Observational Study of Ketamine Infusions for the Treatment of Chronic Pain

— Наблюдательное Chronic Pain

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: Ketamine.
Кому может быть актуально: Состояния в реестре: Chronic Pain. 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: 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

Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes

Обзор

This observational study will collect prospectively specified data on patient characteristics and clinically relevant outcomes in patients who receive a ketamine infusion at Stanford Pain Management Center for the treatment of chronic pain, with the goal of identifying treatment responders and relationships between patient characteristics and treatment response.

Подробное описание

Ketamine is a type of anesthetic drug which has been used off-label to treat chronic pain. The effectiveness of intravenous ketamine and its duration of effect are not well-understood. There is high variability in response to ketamine, and it remains unclear which patient characteristics are associated with favorable outcomes. This observational study will collect a wide range of patient-reported outcomes via digital surveys: once at baseline before treatment, and up to 7 follow-up surveys for up to 12 months following a single ketamine infusion. Survey data will be supplemented by clinical data obtained from electronic medical records.

Вмешательства

Препарат Ketamine
A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting

Первичные конечные точки

Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale [Срок оценки: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)]

Вторичные конечные точки (1)

Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS) [Срок оценки: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)]

Критерии участия

Критерии включения

Has been seen at Stanford's Pain Management Center for a doctor's visit at least once.
Is scheduled to undergo at least 1 ketamine infusion for the treatment of any chronic pain condition.
Have a valid email address and consents to receiving surveys by email.
Able to read, understand, and respond to English-language surveys on an electronic device such as a cell phone, tablet, or computer.
Able to read, understand, and provide written, dated informed consent.