NCT05808881撤回4 期
Clinical Outcomes From Injectable Nalmefene in the Emergency Department (COINED)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Reversal of Respiratory Depression
研究概览
简要总结
The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.
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
- None
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
- •Presumed or known opioid overdose in community settings.
- •Experiencing clinically significant respiratory depression based on appropriate medical judgement.
- •Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
- •Pre-hospital naloxone administration is allowed.
排除标准
- •Patient age known or estimated to be less than 18 years.
- •Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome.
- •Cardiac arrest, secondary to opioid intoxication.
- •Arrested, jailed, or imprisoned patients.
- •Inappropriate for the study per judgement of research team.
研究组 & 干预措施
Nalmefene
Experimental
Nalmefene hydrochloride (HCl) injection
干预措施: Nalmefene Hydrochloride Injection (Drug)
Naloxone
Active Comparator
Naloxone hydrochloride (HCl) injection
干预措施: Naloxone Hydrochloride Injection (Drug)
结局指标
主要结局
Reversal of Respiratory Depression
时间窗: Up to 3 hours
Normalization of the end tidal carbon dioxide value (if measured) to between 35 and 45 mmHg and/or ≥5 breaths per minute increase in respiratory rate from baseline (pre-dose) measurement, with rate of at least 12 breaths per minute.
次要结局
- Time to Reversal from administration of opioid antagonist(Up to 3 hours)
- Recurrence of Respiratory Depression(Up to 3 hours)
- ED Disposition(Up to 3 hours)
- Drug Dosing(Up to 3 hours)
- Richmond-Agitation Sedation Scale (RASS) Score(Up to 3 hours)
- Clinical Opioid Withdrawal Scale (COWS) Score(Up to 3 hours)
- Oxygen saturation level(Up to 3 hours)
- Length of time during ED encounter(Up to 3 hours)
研究者
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