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

April 27, 2026 updated by: University Hospital, Clermont-Ferrand

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
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)
patients randomized in the "SOC" arm will receive analgesic treatment according to the department's internal pain management protocol.
Experimental: SST 30 mcg
Patients randomized to the "SST 30 mcg" arm will receive a 30-microgram sublingual sufentanil tablet.
Drug: sufentanil sublingual 30 mcg tablet
patient randomized in the "SST 30mcg" arm will receive a 30-microgram sublingual sufentanil tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
Hour 0 ; Hour 0 + 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between randomization groups of potential adverse effects.
Time Frame: 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.
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.
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Breath frequency variations
Time Frame: 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
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
Assessment of patient satisfaction with pain management using a 10-point scale
Time Frame: 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."
Hour 0 + 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Farès MOUSTAFA, PR, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Estimated)

April 22, 2027

Study Completion (Estimated)

April 22, 2027

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2024 MOUSTAFA
  • 2024-519217-64-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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