Using sublingual sufentanil for managing moderate to severe pain in emergencies.
Official title: Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
Run by University Hospital, Clermont-Ferrand · NCT06917651 · Data updated 2026-11-12
This study is testing if a new way of giving sufentanil under the tongue can help adults with moderate to severe pain from injuries feel better faster in emergency situations compared to regular pain management methods.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (France) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | April 22, 2027 |
| Study ends | April 22, 2027 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT06917651 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults experiencing moderate to severe pain from a single traumatic injury in the upper or lower limbs.
✕Probably not a fit
Patients with polytrauma, those requiring intravenous access, or individuals with contraindications to the analgesic protocol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of sublingual sufentanil in managing moderate to severe pain in patients with monotraumatic injuries in emergency situations. The study aims to address the delays in pain management often experienced in emergency departments by comparing the sublingual administration of sufentanil to standard care practices. Participants will be adults with a pain rating of 4 or higher on a numerical scale, and the trial will assess the speed and effectiveness of pain relief provided by the sublingual route. The goal is to improve patient outcomes by providing timely analgesia without the need for intravenous access.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time patients wait for effective pain relief in emergency settings.
How similar studies have gone: Other studies have shown promise in using alternative routes of opioid administration for pain management, but this specific approach with sublingual sufentanil is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHU de Clermont-Ferrand, Clermont-Ferrand
France, France Recruiting
Study contacts
- Principal investigator: Farès MOUSTAFA, PR — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.