2024-518043-38-00撤回3 期
MOOD - MethOxyflurane analgesia in vasoOcclusive crises of sickle cell Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 198
- 试验地点
- 3
- 主要终点
- The mean pain intensity measured by VAS (Visual Analogic Scale) every 10 minutes during the first hour after admission in the emergency department
研究概览
简要总结
To compare the analgesic rapidity and efficiency of inhaled Methoxyflurane to oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®) as initial analgesic in SCD patients visiting emergency department for VOC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient with sickle cell disease (SS, Sbeta0, SC or Sbéta+ genotypes)
- •Aged over eighteen years-old
- •Consulting the emergency department for vaso-occlusive crisis with pain intensity over 6 (moderate to severe pain) as measured using the VAS (Visual Analogic Scale)
- •Requiring intravenous morphine
- •For child-bearing aged women, efficient contraception
- •Social security affiliation
- •Informed consent (patient), with possibility of an emergency procedure with deferred written consent only if the pain is too strong and if prior oral consent obtained
- •French-speaking
排除标准
- •Refusal to participate
- •Clinically evident respiratory depression
- •Acute chest syndrome suspected at admission: Chest pain and oxygen saturation under 95%.
- •Vital function failure requiring hospitalization in intensive care unit
- •Contraindication for oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®)
- •Previous inclusion in the MOOD study
- •Pregnant woman
- •Breast feeding
- •Patient under guardianship, administrative tutorship, deprived of liberty and incapable to giving informed consent
- •Inability to use Penthrox® or oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®) : patients who are unable to understand or comply with the mode of administration (cognitive impairment, altered level of consciousness, or physical limitations preventing self-administration)
- •Contraindication for Méthoxyflurane (Penthrox®)
- •Altered level of consciousness due to any cause; sleepiness
- •Clinically evident cardiovascular instability
结局指标
主要结局
The mean pain intensity measured by VAS (Visual Analogic Scale) every 10 minutes during the first hour after admission in the emergency department
The mean pain intensity measured by VAS (Visual Analogic Scale) every 10 minutes during the first hour after admission in the emergency department
次要结局
- Patient's satisfaction measured at the 60th minute by Likert scale ranging from 1 to 10.
- Global ED nurse's satisfaction measured within the first 8h by Likert scale ranging from 1 to 10.
- Total amount (in milligram) of intravenous morphine and analgesics (Nefopam, Paracetamol, and Tramadol) administered until emergency discharge
- Duration of stay (in days) from arrival to emergency department to the end of hospitalization.
- Calculation of the cost of Penthrox® (number of bottles used)
- Calculation of the cost of oral administration of opioid analgesics (number of pills used), such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan® )
- Incidence of renal and liver events based on the difference of kidney and liver function between the time of emergency admission and the third to seventh day of hospitalization (if several values are available, the worse value is retained)
- Incidence of acute chest syndrome during hospitalization
- Incidence of neurologic events such as ischemic stroke
研究者
Richard CHOCRON
Scientific
Assistance Publique Hopitaux De Paris
研究点 (3)
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