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

Phase 3

Recruiting

• Conditions: Pain Management
• Interventions: Other: Standard of Care (SOC); Drug: sufentanil sublingual 30 mcg tablet

• Registration Number: NCT06917651
• Lead Sponsor: University Hospital, Clermont-Ferrand

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-08
• Study Start: 2025-04-22
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care (SOC)	Patient randomized to the "standard of care" arm will receive analgesic treatment according to the department's internal pain management protocol.
SST 30 mcg	sufentanil sublingual 30 mcg tablet	Patients randomized to the "SST 30 mcg" arm will receive a 30-microgram sublingual sufentanil tablet.

Primary Outcome Measures

Name	Time	Method
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	Hour 0 ; 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

Secondary Outcome Measures

Name	Time	Method
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	Oxygen saturation variation in patients at different time points, measured using a pulse oximeter.
Breath frequency 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	variation of breath frequency measured at differents time points
Assessment of patient satisfaction with pain management using a 10-point scale	Hour 0 + 180 minutes	Assessment of patient satisfaction with pain management using a 10-point scale, where 0 represents "very dissatisfied" and 10 represents "very satisfied."
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	Heart rate variation in patients at different time points, measured using a heart rate monitor.
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	Safety outcomes : The comparison between randomization groups of potential adverse effects: hypotension, bradycardia, respiratory depression, sweating, drowsiness, nausea and/or vomiting, dizziness.
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	Pain variation assessed in both groups at different time points of the study. Pain will be evaluated using the NRS, à 10-point scale, where 0 corresponds to no pain and 10 to the most intense pain.
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	Blood pressure variation in patients at different time points, measured using an automatic sphygmomanometer.

Trial Locations

Locations (1)

CHU de Clermont-Ferrand, Clermont-Ferrand; 🇫🇷 France, France