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Идёт набор NCT07369024

Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults

Фаза II С лечением Sickle Cell Disease Vaso-Occlusive Pain Episode in Sickle Cell Disease Ketamine Infusion Pain Management

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: Sub-dissociative Ketamine Infusion, Normal Saline Placebo Infusion.
Кому может быть актуально
Состояния в реестре: Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Ketamine Infusion, Pain Management. Базовые параметры: 5 лет — 20 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
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Официальное название

Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial

Обзор

The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease experiencing sickle cell related pain. In this study, we will compare the outcomes (such as pain scores) in persons who receive standard of care pain medicine (an opioid such as morphine) plus a low dose (amount) of ketamine to those who receive only standard of care pain medicine.

Вмешательства

  • Препарат Sub-dissociative Ketamine Infusion
    0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
  • Препарат Normal Saline Placebo Infusion
    20-minute infusion of 100 milliliters of normal saline

Первичные конечные точки

  • Total Opioid Medications Required for Analgesia [Срок оценки: Up to 3 days]
Вторичные конечные точки (4)
  • Pain Score [Срок оценки: 30 minutes and 60 minutes after administration of placebo vs ketamine infusion]
  • ED Length of Stay [Срок оценки: Up to 3 days]
  • Rate of Hospitalization [Срок оценки: Up to 1 month]
  • Quality of Life (Pediatric Quality of Life) [Срок оценки: 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study]

Критерии участия

Критерии включения

  • Between the ages 5-20 years
  • Diagnosed sickle cell disease. Homozygous (HbSS) or heterozygous (HbSC, HbSBetaThal Plus or Zero) will be included.
  • Presenting with VOE pain, requiring IV pain medication.
  • First dose of analgesic medication is given before patient approached for participation in the study.
  • Primary language is English or Spanish
  • Adult individual or parent/legal guardian is able and willing to provide informed consent. For individuals 7 to 17 years of age, assent must also be provided when cognitively possible.

Критерии исключения

  • Sickle cell trait only
  • Patients whose primary language is other than English or Spanish
  • Pain attributed to causes other than VOE
  • Not requiring IV for pain treatment
  • No analgesic (e.g. opiate) is given before approach for study participation due to any reason, including problem with IV access.
  • Oxygen saturation < 90% on room air
  • History of prior adverse reaction to ketamine
  • History of hypertension - Patients with active/uncontrolled hypertension defined as systolic 140 mmHg over diastolic of 90 mmHg will be excluded from participation in the study. If hypertension is controlled and at the time of enrollment, systolic and diastolic thresholds of 140 mmHg and 90 mmHg respectively are not exceeded, patient may be included in the study
  • History of significant or uncontrolled cardiovascular disease, liver disease, kidney disease, and thyroid disease
  • Patients with evidence of increased intracranial pressure
  • Patients with elevated intraocular pressure
  • Patients with acute mania or history of bipolar disorder with manic episodes, history of hallucinations or paranoia secondary to previously diagnosed psychiatric condition
  • Pregnant or potentially pregnant patients per patient report. All patients of childbearing potential will undergo pregnancy testing prior to enrollment (as part of clinical care), and if positive, will be excluded.
  • Elevated liver enzymes (alkaline phosphatase, ALT, AST, bilirubin) as sign of hepatic disfunction if the laboratory results are available prior to study participation
  • Patients who appear intoxicated on any substance.
  • Patients who are wards of the state or prisoners as defined by DHS
  • Patients who are not deemed to be competent to provide consent or assent.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Harbor UCLA Medical Center — Torrance

Идентификаторы

NCT: NCT07369024 · 2024-33412-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗