Intranasal Ketamine for Treatment of Acute Pain in the Emergency Department : A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,102
- 试验地点
- 2
- 主要终点
- Number and percentage of patients who need rescue opiods in the two groups
研究概览
简要总结
To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine analgesic agents in patients with moderate to severe pain in the ED in reducing the need for opioid or non opioids analgesic agents.
详细描述
Intranasal ketamine for treatment of acute pain in the emergency department : A randomized controlled trial
Introduction :
Pain is the most common complaint for emergency department (ED) visits [1].The provision of adequate, safe, and timely analgesia is a core component of patient care in the emergency department (ED). Ketamine is a noncompetitive Nmethyl- D-aspartate and glutamate receptor antagonist that decreases central sensitization, "wind-up" phenomena, and pain memory [2,3].
At subdissociative doses (0.1 to 0.6 mg/kg; most commonly 0.3 mg/kg) maintains potent analgesic and amnestic effects that are accompanied by preservation of protective airway reflexes, spontaneous respiration, and cardiopulmonary stability [4-6].
Intranasal route ....
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)
盲法说明
Ketamine versus placebo as a double blind study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study includes patients aged 18 to 80 years who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11- point (0 to 10). An informed consent is necessary.
排除标准
- •- Pregnancy,
- •Breast-feeding,
- •Altered mental status,
- •Allergy to ketamine or morphine or
- •Weight less than 46 kg or greater than 115 kg,
- •Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min),
- •Medical history of acute head or eye injury, seizure, intracranial hypertension, chronic pain, severre renal or hepatic insufficiency,
- •Alcohol or drug abuse,
- •Psychiatric illness,
- •Recent (4 hours before) analgesic agent use.
研究组 & 干预措施
placebo group
Intranasal placebo pulverisation
干预措施: Placebo (Drug)
Ketamine group
Intranasal ketamine pulverisation
干预措施: Ketamine (Drug)
结局指标
主要结局
Number and percentage of patients who need rescue opiods in the two groups
时间窗: 30 minutes
the need for rescue opioids during ED stay
次要结局
- Intolerance to treatement and adverse events(30 minutes and at 120 minutes)
- Percentage of patients with VAS <30 mm at discharge(120 minutes)
- Number and percentage of patients who required non opiods analgesics(30 minutes)
研究者
Pr. Semir Nouira
Professor
University of Monastir