Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 6
- 主要终点
- Efficiency of Analgesia
研究概览
简要总结
Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED).
The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED.
The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates.
The investigators also asses side effects and patient satisfaction in both groups.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic pain
- •Numeric Pain Rating Scale (NPRS) >5 /10
- •Age between 18 and 75 years old
排除标准
- •Medical pain (headache, chest pain,...)
- •Respiratory, renal or hepatic insufficiency
- •Drug addiction
- •Medical or Chirurgical sinus history
- •Oxygene saturation < 90%
- •Systolic blood pressure < 90mmHg
- •Head injury with a neurological Glasgow Coma Scale (GCS) < 14
- •Opioid allergy
- •Facial traumatism
- •Patient unable do understand or assessing NPRS
- •Opiates administration within 6 hours before admission
研究组 & 干预措施
IN Sufentanil AND IV Placebo
Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration
干预措施: Sufentanil (Drug)
IN Sufentanil AND IV Placebo
Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration
干预措施: Placebo (Drug)
IV Morphine AND IN Placebo
Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray
干预措施: Morphine (Drug)
IV Morphine AND IN Placebo
Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray
干预措施: Placebo (Drug)
结局指标
主要结局
Efficiency of Analgesia
时间窗: 30 minutes
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.
次要结局
- Opioid-related side effects(10 minutes)
- Specific Analysis for the pre hospital setting group: Efficiency of Analgesia(Every 10 minutes)
- Efficiency of Analgesia(Every 10 minutes)
- Patient Satisfaction(40 min)
研究者
AdministrateurDRC
Delegation de la recherche clinique et de l'innovation
University Hospital, Grenoble