New Analgesic Strategy Combining Nitrous Oxide, Nefopam, Acetaminophen and Morphine Compared to the Usal Antalgic Strategy (Acetaminophen and Morphine) for the Treatment of Acute Sickle Cell Disease Pain in the Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Rate of pain relief (Numeric Pain Intensity Scale < 4)
研究概览
简要总结
Quality of life of adult patients with sickle cell disease is deeply impaired by severe adverse medical events that inadvertently occur throughout their time life. Indeed, patients not presenting a life threatening condition often present to the emergency department with sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic strategies for treating sickle cell disease crisis related pain are mostly based on acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies are effective but may last up to half an hour to obtain pain relief. This delay mostly depends on the availability of venous access and on individual patient response to treatment. Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to allow rapid analgesia in the emergency department setting.
The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective than current analgesic strategy.
详细描述
Purpose of the study:
The main objective is to evaluate the effectiveness of an optimized combination of analgesic therapies for treating uncomplicated sickle cell disease crisis at initial visit to the emergency room of the Henri Mondor hospital.
Secondary objectives:
- Total amount of morphine required during the first 4 hours in the hospital emergency.
- Overall amount of morphine administered on the duration of patient stay in hospital Henri Mondor.
- Side effects of analgesic strategies
- Adverse medical events
- Length of hospital stay.
- 7-day and 1-month follow-up and collection of following data:
- Total number of sickle cell disease crises
- Number of subsequent readmission and/or visit to an ED
- Quality of life (EuroQol EQ-5D, and SF-36)
- Patient satisfaction: pain treatment satisfaction scale. Study design: prospective monocentric open-label randomized controlled trial Number of patients: 200 Follow up per patient: 1 month, Study enrolment period: 25 months.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •male adult patient with sickle cell anemia,
- •age ≥ 18 years,
- •main complaint : sickle cell crisis pain,
- •initial numeric pain intensity scale at presentation > 4,
- •admission to the ED during working hours (amendment n°2-15/02/2010:from 8h to 20h), from Monday to Friday
排除标准
- •female adult patient
- •complicated sickle cell crisis or admission requirement to an ICU
- •recent hospitalisation (< 10 days) for the same complaint
- •previous inclusion in the study
- •contraindication to anyone of the study drugs
- •no medical insurance
- •incompetent adult
研究组 & 干预措施
2
Combination of acetaminophen, morphine
干预措施: current analgesic strategy (Drug)
1
Combination of acetaminophen, nitrous oxide, nefopam, morphine
干预措施: Rapid optimized analgesic strategy (Drug)
结局指标
主要结局
Rate of pain relief (Numeric Pain Intensity Scale < 4)
时间窗: at 30 min after admission to the ED
次要结局
- Overall amount of morphine delivered(during the hospital stay following ED presentation and enrolment in the study)
- Analgesic drugs related adverse events(during the hospital stay following ED presentation and enrolment in the study)
- Length of hospital stay(during the hospital stay)
- Overall number of sickle cell crisis and patients'quality of life (EuroQol-EQ 5D, SF-36) and patients' satisfaction regarding pain management (pain management satisfaction questionnaire)(at 7 days and 30 days of follow-up.)
- measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009)(in 4hours after admission to the emergency)