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

NCT06917651 | Recruiting Phase 3

• 2 other identifiers: RBHP 2024 MOUSTAFA2024-519217-64-00
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Conditions

Pain Management

Keywords

pain; sublingual sufentanil; traumatic pain

Outcome Measures

Primary Outcomes (1)

• 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

  the efficacy of sublingual sufentanil will be measured by the difference in pain scores measured by the NRS between baseline and 60 minutes after receiving treatment NRS is a 10-point scale where 0 means no pain and 10 means the most pain

  Hour 0 ; Hour 0 + 60 minutes

Secondary Outcomes (7)

• Comparison between randomization groups of potential adverse effects.

  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

• Pain variation assessed at different time points.

  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

• Blood pressure variations

  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

• Heart rate variations

  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

• Oxygen saturation variation

  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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care (SOC)

SST 30 mcg

EXPERIMENTAL

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

Drug: sufentanil sublingual 30 mcg tablet

Interventions

sufentanil sublingual 30 mcg tablet DRUG

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

SST 30 mcg

Standard of Care (SOC) OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Polytrauma
• Analgesic treatment within the 4 hours preceding admission (except paracetamol)
• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand, Clermont-Ferrand

France, France

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Tablets; Standard of Care

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Farès MOUSTAFA, PR

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 8, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)