Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
Recruiting
Phase 3
Interventional Study
Pain Management
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- University Hospital, Clermont-Ferrand · Other
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About This Trial
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…
Trial Locations
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Eligibility 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 prece…
Contacts