Morphine or Ketamine for Analgesia

Официальное название

Efficacy of Intravenous Sub-Dissociative Ketamine Versus Intravenous Morphine in Children With Acute Pain

Обзор

Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.

Подробное описание

Aim 1: To determine if IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children presenting to an ED with acute pain. The investigators hypothesize that IV sub-dissociative ketamine is non-inferior to IV morphine for decreasing pain intensity in children with acute abdominal pain or an extremity fracture.

Aim 2: To compare the rate of acute (\<2 hours) adverse events, including cardiopulmonary adverse events, associated with IV sub-dissociative ketamine and IV morphine. The investigators hypothesize that there is a smaller proportion of cardiopulmonary adverse events associated with IV sub-dissociative ketamine compared to IV morphine.

Aim 3: To determine the relationship between ketamine and long-term sequelae of acute pain. The investigators hypothesize that children who receive ketamine will have better levels of pain-related function during the first week following ED presentation and will have greater odds of experiencing more favorable post-traumatic stress, anxiety and depression outcomes 1-6 months after ED presentation compared to children who received IV morphine.

Вмешательства

• Препарат Ketamine hydrochloride
  Sub-dissociative ketamine, IV
• Препарат Morphine sulphate
  Morphine, IV

Первичные конечные точки

• Pain intensity [Срок оценки: Up to 120 minutes after completion of study drug administration or until a terminal event occurs]
• Adverse events, acute [Срок оценки: Up to 120 minutes after completion of study drug administration or until a terminal event occurs]
• Pain-related function [Срок оценки: Days 1, 2,3, 7 and 30 after discharge.]
• Traumatic stress, primary assessment [Срок оценки: Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.]

Вторичные конечные точки (9)

• Receipt of rescue analgesia [Срок оценки: Up to 120 minutes after completion of study drug administration or until a terminal event occurs]
• Desire for same analgesic [Срок оценки: At 240 minutes after completion of study drug administration or when a terminal event occurs]
• Depth of sedation [Срок оценки: Up to 120 minutes after completion of study drug administration or until a terminal event occurs]
• Analgesic/opioid use after discharge [Срок оценки: Days 1, 2, 3, 7, 30, 90, and 180 after discharge]
• Missed school or work [Срок оценки: Day 7, 30, 90, 180 after discharge]
• Return visit [Срок оценки: Day 7, 30, 90, 180 after discharge]
• Anxiety [Срок оценки: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge]
• Depression [Срок оценки: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge]
• Substance use [Срок оценки: Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge]

Критерии участия

Критерии включения

• Abdominal pain or isolated long-bone extremity fracture (suspected or proven)
• Self-reported pain score of ≥ 6/10
• Requires IV morphine for analgesia as determined by the treating physician

Критерии исключения

• Weight > 82.4 kg
• Known allergy/contraindication to morphine or ketamine
• Antecedent receipt of ketamine related to presenting complaint
• Inability to use self-report measures of pain or questionnaires
• Chronic disease associated with pain
• Chronic pain condition requiring use of opioids as outpatient
• Hemodynamic instability or critical illness per treating physician
• Altered mental state (e.g., GCS , 14 or clinical intoxication)
• Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta
• Concern for open fracture, neurovascular compromise, or compartment syndrome
• Injuries in addition to the extremity injury (e.g., head, neck, abdomen)
• Known or reported pregnancy
• Does not speak English or Spanish
• Patient previously enrolled in this study
• Wards of state, foster children, or children in custody

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

США · 8 центров

• Children's Hospital Los Angeles — Los Angeles
• UC Davis Children's Hospital — Sacramento
• Nemours Children's Hospital — Wilmington
• Arthur M. Blank Hospital — Atlanta
• NewYork Presbyterian Morgan Stanley Children's Hospital — New York
• UPMC Children's Hospital of Pittsburgh — Pittsburgh
• Seattle Children's Hospital — Seattle
• Children's Wisconsin — Milwaukee

Идентификаторы

NCT: NCT06835504 · AAAV7115 · U01HD116253 · IRB00181652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗