NCT05671913撤回早期 1 期
Effects of Opioid Requirements With Scheduled Intranasal Ketamine During Admission for Traumatic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Total Morphine Equivalents (TME) throughout hospitalization
研究概览
简要总结
The purpose of this research is to determine if scheduled intranasal ketamine effects opioid requirements in adult trauma patients with moderate to severe pain in the inpatient setting.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between aged 18-80 years, present following a traumatic incident, rate pain > 5 on the numeric rating scale (NSR), and require admission to the hospital.
排除标准
- •- Patients that arrive at facility intubated
- •Patients that received Ketamine in the field
- •Patients less than 18 years old or greater than 80 years
- •Pregnant or breast-feeding females
- •Hemodynamic instability defined as need for vasoactive drugs or Systolic blood pressure >180
- •Weight less than 80 pounds or greater than 300 pounds
- •Glasgow Coma Scale less than 15
- •Current acute head injury resulting in unconsciousness
- •Current or history of eye injury
- •Current or history of seizures
- •Facial or nasal fractures that require nasal precautions
- •Current or history of intracranial hypertension
- •History of Schizophrenia
- •BAC (Blood Alcohol Content) greater than 0.08
- •Current alcohol abuse
- •Current drug abuse or positive drug screen
- •Chronic pain or patients on pain contracts
- •Inability to assess pain intensity
- •Contraindications or allergies to the treatment
- •Patients with hepatic insufficiency
- •Prisoners
- •Nursing home residents
- •Urine drug screen positive for illicit drugs or medications not on their home medication list.
- •BAC > 0.08
- •Positive pregnancy test
研究组 & 干预措施
Treatment
Active Comparator
Intranasal Ketamine
干预措施: Ketamine (Drug)
Control
Placebo Comparator
Normal Saline
干预措施: Placebo (Drug)
结局指标
主要结局
Total Morphine Equivalents (TME) throughout hospitalization
时间窗: 72 hours
Total Morphine Equivalents is a standardized way of measuring opioids that patients receive over time. This will be calculated by a member of the research study team utilizing a standardized formula under pharmacies direction. The Medication Administration Record (MAR) will be reviewed to gather administered doses of opioids throughout the participants hospital stay.
次要结局
未报告次要终点
研究者
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