Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total Daily Opioid Requirement
研究概览
简要总结
This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Total Injury Severity Score greater than 9
- •Functioning intravenous catheter present per standard of care
- •Patient planned to receive PCA for acute pain per standard of care
- •Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
- •Negative pregnancy test for women of childbearing age
排除标准
- •Body mass index greater than 35
- •History of active psychiatric disease
- •Acute or chronic liver or renal failure
- •History of heart failure or coronary artery disease
- •Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
- •Patients who abuse alcohol and are at high risk for alcohol withdrawal
- •Intubated patients
- •Glasgow Coma Scale score less than 13, or motor subscore less than 6
- •Documented allergy to ketamine, hydromorphone, or lorazepam
- •Pregnancy
- •Incarceration
研究组 & 干预措施
Ketamine
Ketamine 90mg/30 mL PCA (3 mg/mL)
干预措施: Ketamine (Drug)
Hydromorphone
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Total Daily Opioid Requirement
时间窗: Participants will be followed for their entire hospital stay, an expected average of 1 week.
Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents
次要结局
- Breakthrough Daily Opioid Requirement(Participants will be followed for their entire hospital stay, an expected average of 1 week)
- Median Pain Score(Participants will be followed for their entire hospital stay, an expected average of 1 week)
研究者
Sheila Takieddine
Policy Development Specialist
University of Cincinnati