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Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.

RecruitingPhase 3Ages 18 Years - anyAllUniversity Hospital, Clermont-Ferrand
NCT06917651 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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), whic

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • sufentanil sublingual 30 mcg tablet
  • Standard of Care (SOC)
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Where

1 site
CHU de Clermont-Ferrand, Clermont-Ferrand
France, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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