Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation. (SubSUF-ER)

University Hospital, Clermont-Ferrand

Status and phase: Enrolling; Phase 3

Conditions: Pain Management

Treatments: Drug: sufentanil sublingual 30 mcg tablet; Other: Standard of Care (SOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06917651

RBHP 2024 MOUSTAFA

2024-519217-64-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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)

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Patient randomized to the "standard of care" arm will receive analgesic treatment according to the department's internal pain management protocol.

Treatment:

Other: Standard of Care (SOC)

SST 30 mcg

Experimental group

Description:

Patients randomized to the "SST 30 mcg" arm will receive a 30-microgram sublingual sufentanil tablet.

Treatment:

Drug: sufentanil sublingual 30 mcg tablet