Идёт набор NCT03427736

Anesthetics and Analgesics in Children

— Наблюдательное Anesthesia 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: Ketorolac Tromethamine, Hydromorphone, Ketamine, Oxycodone.
Кому может быть актуально: Состояния в реестре: Anesthesia, Pain. Базовые параметры: 0 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: США, 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

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

Обзор

The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.

Подробное описание

This is a research study to find out what the side effects are of certain drugs that are commonly used for pain and to put people to sleep for surgery. The researchers also want to know how the drug is broken down in the body. Participants will be given these drugs as they are prescribed by their regular doctor. As part of the participant's standard of care, doctors will perform tests, ask questions, review medical information and measure vital signs (heart rate, blood pressure, etc). The researchers will collect information that doctors have already written in the medical records. The research study team will collect blood from participants at certain time points depending on when the participant was first given the drug (up to 5 samples over the course of 10 to 48 hours). Examples of current and upcoming anesthetics and analgesics include, but are not limited to: ketorolac (Toradol), ketamine (Ketalar), oxycodone (OxyContin), and morphine (Kadian, MS Contin).

Вмешательства

Препарат Ketorolac Tromethamine
IV ketorolac will be given per standard of care, not prescribed for this study
Препарат Hydromorphone
IV Hydromorphone will be given per standard of care, not prescribed for this study
Препарат Ketamine
IV Ketamine will be given per standard of care, not prescribed for this study
Препарат Oxycodone
PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study
Препарат Morphine
IV Morphine will be given per standard of care, not prescribed for this study

Первичные конечные точки

Clearance (CL) or apparent oral clearance (CL/F) [Срок оценки: up to 48 hours post dose]
Volume of distribution (V) or apparent oral volume of distribution (V/F) [Срок оценки: up to 48 hours post dose]
Elimination rate constant (ke) [Срок оценки: up to 48 hrs post dose]
Half-life (t1/2) [Срок оценки: up to 48 hrs post dose]
Absorption rate constant (ka) [Срок оценки: up to 48 hrs post dose]
Area under the curve (AUC) [Срок оценки: up to 48 hrs post dose]
Maximum concentration (CMAX) [Срок оценки: up to 48 hrs post dose]
Time to achieve maximum concentration (TMAX) [Срок оценки: up to 48 hrs post dose]

Критерии участия

Критерии включения

0 to <18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range)
Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
Receiving one or more drugs of interest (DOI) per local standard of care
Meeting DOI-specific inclusion criteria (See Appendices)

Критерии исключения

Known pregnancy
Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

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

Здоровые добровольцы: Нет