A Randomized, Placebo-Controlled, Double-Blind Evaluation of Low-Dose Ketamine Infusion During Burn Wound Care Procedures to Improve Pain Intensity and Reduce Opioid Consumption
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Analgesia
研究概览
简要总结
The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.
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)
盲法说明
All team members and patients are blinded to study treatment, except pharmacy staff.
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
- •Admitted to burn service with thermal injury
排除标准
- •unable/unwilling to consent within 72 hours
- •unable to report NRS
- •known contraindication to ketamine
- •< than 18 years of age
- •incarcerated
- •TBSA over 50 %
研究组 & 干预措施
Ketamine
Ketamine infusion (0.3 mg/kg/hr) to begin 1 hour before wound care, continuing through and for 1 hour following wound care.
干预措施: Ketamine (Drug)
Placebo
0.9% saline to begin 1 hour before wound care, continuing through and for 1 hour following wound care.
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
Analgesia
时间窗: up to 7 days from enrollment
Numeric Pain Rating Scale (0 - 10, with 0 being absence of pain and 10 being the worst pain imaginable)
次要结局
未报告次要终点