Clinical trial NCT06917651: Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
Official title: Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain Management
Keywords: pain
sublingual sufentanil
traumatic pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)


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 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

Primary outcomes:
measure: To determine the effectiveness of sublingual sufentanil compared to the standard analgesic protocol used in the department, by measuring pain scores on the Numerical Rating Scale from 0 to 10 at Hour 0 and Hour 0 +60 minutes
timeFrame: Hour 0 ; Hour 0 + 60 minutes
Secondary outcomes:
measure: Comparison between randomization groups of potential adverse effects.
timeFrame: Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes
measure: Pain variation assessed at different time points.
timeFrame: Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes
measure: Blood pressure variations
timeFrame: Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes
measure: Heart rate variations
timeFrame: Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes
measure: Oxygen saturation variation
timeFrame: Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes
measure: Breath frequency variations
timeFrame: Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes
measure: Assessment of patient satisfaction with pain management using a 10-point scale
timeFrame: Hour 0 + 180 minutes
Other outcomes:
Locations:
city: France
country: France
facility: CHU de Clermont-Ferrand, Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Farès MOUSTAFA, PR
role: PRINCIPAL_INVESTIGATOR
References: