Status:
RECRUITING
Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Pain Management
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06917651
Start Date
April 22 2025
End Date
January 31 2026
Last Update
April 29 2025
Active Locations (1)
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1
CHU de Clermont-Ferrand, Clermont-Ferrand
France, France