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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2026-01-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

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

Group Type ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type OTHER

patients randomized in the "SOC" arm will receive analgesic treatment according to the department's internal pain management protocol.

SST 30 mcg

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

Group Type EXPERIMENTAL

sufentanil sublingual 30 mcg tablet

Intervention Type DRUG

patient randomized in the "SST 30mcg" arm will receive a 30-microgram sublingual sufentanil tablet

Interventions

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sufentanil sublingual 30 mcg tablet

patient randomized in the "SST 30mcg" arm will receive a 30-microgram sublingual sufentanil tablet

Intervention Type DRUG

Standard of Care (SOC)

patients randomized in the "SOC" arm will receive analgesic treatment according to the department's internal pain management protocol.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No