Actively Recruiting
Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
Led by University Hospital, Clermont-Ferrand · Updated on 2026-04-28
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient
- Pain rating on the Numerical Rating Scale (NRS) of 4 or higher
- Pain caused by a single trauma to the upper or lower limb
- Fully alert with a Glasgow Coma Scale score of 15
- Oxygen saturation above 95% while breathing ambient air
You will not qualify if you...
- Multiple traumas (polytrauma)
- Use of analgesic treatment within 4 hours before admission (except paracetamol)
- Women of childbearing age without effective contraception, pregnant or at risk of pregnancy, breastfeeding, or positive pregnancy test at inclusion
- Need for intravenous access upon admission (e.g., displaced open fracture)
- Allergy or contraindication to any drug in the analgesia protocol
- Refusal to participate in the study
- Known substance abuse or psychiatric disorders
- Known oxygen dependence or chronic obstructive pulmonary disease (COPD)
- Not covered by social security
- Under guardianship, curatorship, deprived of liberty, or under legal protection
- Unable to speak or read French
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU de Clermont-Ferrand, Clermont-Ferrand
France, France
Actively Recruiting
Research Team
L
Lise Laclautre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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