Efficacy of Intravenous Sub-Dissociative Ketamine Versus Intravenous Morphine in Children With Acute Pain
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,010
- 试验地点
- 8
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sub-dissociative ketamine
0.25 mg/kg, maximum dose 25 mg
干预措施: Ketamine hydrochloride (Drug)
Morphine
0.1 mg/kg, maximum dose 8 mg
干预措施: Morphine sulphate (Drug)
结局指标
主要结局
Pain intensity
时间窗: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Self-reported pain intensity measured using the Verbal Numerical Rating Scale (VNRS). Scored from 0 to 10. A higher score indicates a worse outcome.
Adverse events, acute
时间窗: Up to 120 minutes after completion of study drug administration or until a terminal event occurs
Examples of adverse events include, but are not limited to, cardiopulmonary adverse events (e.g., hypoxia, respiratory depression, hypotension); opioid-related adverse events; and adverse events as measured using the Side Effects Rating Scale of Dissociative Anesthetics (SERSDA).
Pain-related function
时间窗: Days 1, 2,3, 7 and 30 after discharge.
Pain intensity and related functional limitations due to pain, measured using the Parents' Postoperative Pain Measure (PPPM). Scored from 0 to 10. A higher score indicates a worse outcome.
Traumatic stress, primary assessment
时间窗: Baseline (at time of enrollment) and days 7, 30, 90 and 180 after discharge.
Stress related to the pain experienced measured using the Child Stress Disorder Checklist (CSDC-SF). Scored from 0 to 8. A higher score indicates a worse outcome.
次要结局
- Receipt of rescue analgesia(Up to 120 minutes after completion of study drug administration or until a terminal event occurs)
- Desire for same analgesic(At 240 minutes after completion of study drug administration or when a terminal event occurs)
- Depth of sedation(Up to 120 minutes after completion of study drug administration or until a terminal event occurs)
- Analgesic/opioid use after discharge(Days 1, 2, 3, 7, 30, 90, and 180 after discharge)
- Missed school or work(Day 7, 30, 90, 180 after discharge)
- Return visit(Day 7, 30, 90, 180 after discharge)
- Anxiety(Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge)
- Depression(Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge)
- Substance use(Baseline (at time of enrollment) and days 7, 30, 90, and 180 after discharge)
研究者
Daniel S Tsze, MD, MPH
Professor of Pediatrics in Emergency Medicine
Columbia University