Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To determine the effectiveness of sublingual sufentanil compared to the standard analgesic protocol used in the department, by measuring pain scores on the Numerical Rating Scale from 0 to 10 at Hour 0 and Hour 0 +60 minutes
研究概览
简要总结
Pain is a common reason for emergency department (ED) visits. However, studies suggest that emergency physicians may not always provide optimal analgesic treatment due to various factors, such as time constraints, demographic factors like gender and age, and concerns about opioid use. As a result, patients with moderate to severe pain often experience long delays before receiving analgesia and may even be discharged with unresolved pain or suboptimal treatment. Additionally, diagnostic procedures for patients with isolated trauma (e.g., clinical examinations, radiographs) can lead to variations in pain levels, making it difficult to assess the effectiveness of analgesia.
A commonly used treatment for moderate to severe pain is intravenous opioid administration. However, this approach requires longer wait times, complex titration, and significant resources (beds, nurses, equipment), which may be limited during peak hours. While oral opioids require fewer resources, their delayed onset and limited titratability restrict their use for severe pain.
The sublingual sufentanil tablet (30 mcg), delivered via a single-dose applicator, was developed for patients with moderate to severe pain in emergency or outpatient surgical settings. Its unique pharmacokinetic and pharmacodynamic properties could offer advantages in non-invasive acute pain management.
Sublingual sufentanil received market authorization in June 2018 for the treatment of moderate to severe acute pain in adults and is already used in many hospitals. However, further studies are needed to confirm its effectiveness and potential superiority in pain management.
The objective of this study is to evaluate the effectiveness of 30 mcg sublingual sufentanil in patients admitted for moderate to severe pain due to isolated trauma. This will be compared to the standard pain management protocol used in the Clermont-Ferrand emergency department, focusing on pain score variations using a numerical rating scale (0-10)
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
- •Adult patient
- •Patient with a pain rating on the Numerical Rating Scale (NRS) ≥ 4
- •Pain of monotraumatic origin in the upper or lower limb
- •Glasgow Coma Scale = 15
- •SaO2 > 95% in ambient air
排除标准
- •Polytrauma
- •Analgesic treatment within the 4 hours preceding admission (except paracetamol)
- •Woman of childbearing age without effective contraception, declaring pregnancy or at risk of pregnancy, breastfeeding woman, or positive pregnancy test at inclusion
- •Patient requiring intravenous access upon admission (e.g., displaced open fracture)
- •Contraindication or allergy to any of the molecules in the analgesia protocol
- •Refusal to participate
- •Known substance abuse or psychiatric disorders
- •Known oxygen dependence or COPD
- •Not affiliated with social security
- •Patient under guardianship, curatorship, deprived of liberty, or under legal protection
- •Patient who does not speak or read French
研究组 & 干预措施
Standard of Care
Patient randomized to the "standard of care" arm will receive analgesic treatment according to the department's internal pain management protocol.
干预措施: Standard of Care (SOC) (Other)
SST 30 mcg
Patients randomized to the "SST 30 mcg" arm will receive a 30-microgram sublingual sufentanil tablet.
干预措施: sufentanil sublingual 30 mcg tablet (Drug)
结局指标
主要结局
To determine the effectiveness of sublingual sufentanil compared to the standard analgesic protocol used in the department, by measuring pain scores on the Numerical Rating Scale from 0 to 10 at Hour 0 and Hour 0 +60 minutes
时间窗: Hour 0 ; Hour 0 + 60 minutes
the efficacy of sublingual sufentanil will be measured by the difference in pain scores measured by the NRS between baseline and 60 minutes after receiving treatment NRS is a 10-point scale where 0 means no pain and 10 means the most pain
次要结局
- Oxygen saturation variation(Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes)
- Breath frequency variations(Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes)
- Assessment of patient satisfaction with pain management using a 10-point scale(Hour 0 + 180 minutes)
- Heart rate variations(Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes)
- Comparison between randomization groups of potential adverse effects.(Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes)
- Pain variation assessed at different time points.(Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes)
- Blood pressure variations(Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes)