Pain ManagementPhase 3SubSUF-ERNCT06917651
Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
A Phase 3 study testing sufentanil sublingual 30 mcg tablet in people with Pain Management, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- sufentanil sublingual 30 mcg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2025to 22 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand, Clermont-Ferrand
France
Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Farès MOUSTAFA
About this study
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.
Read more
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
- Being tested
- sufentanil sublingual 30 mcg tablet, Standard of Care (SOC)
- Keywords
- pain, sublingual sufentanil, traumatic pain
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanil sublingual 30 mcg tabletDrug
patient randomized in the "SST 30mcg" arm will receive a 30-microgram sublingual sufentanil tablet
Standard of Care (SOC)Other
patients randomized in the "SOC" arm will receive analgesic treatment according to the department's internal pain management protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: sufentanil sublingual 30 mcg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Hour 0 ; Hour 0 + 60 minutes
Secondary outcomes (7)
Comparison between randomization groups of potential adverse effects.
Safety outcomes : The comparison between randomization groups of potential adverse effects: hypotension, bradycardia, respiratory depression, sweating, drowsiness, nausea and/or vomiting, dizziness.
Measured: 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.
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.
Measured: 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
Blood pressure variation in patients at different time points, measured using an automatic sphygmomanometer.
Measured: 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
Heart rate variation in patients at different time points, measured using a heart rate monitor.
Measured: 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
Oxygen saturation variation in patients at different time points, measured using a pulse oximeter.
Measured: 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
variation of breath frequency measured at differents time points
Measured: 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
Assessment of patient satisfaction with pain management using a 10-point scale, where 0 represents "very dissatisfied" and 10 represents "very satisfied."
Measured: Hour 0 + 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start22 Apr 2025
- Primary completion22 Apr 2027 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farès MOUSTAFA, PR, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917651
- Sponsor's protocol ID
- RBHP 2024 MOUSTAFA
- Other IDs
- 2024-519217-64-00
- Acronym
- SubSUF-ER
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.
- ClinicalTrials.gov ID
- NCT06917651
- Acronym / sponsor ID
- SubSUF-ER / RBHP 2024 MOUSTAFA
- Conditions
- Pain Management
- Keywords
- pain, sublingual sufentanil, traumatic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: 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 | Experimental | Drug: sufentanil sublingual 30 mcg tabletPatients randomized to the "SST 30 mcg" arm will receive a 30-microgram sublingual sufentanil tablet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sufentanil sublingual 30 mcg tabletpatient randomized in the "SST 30mcg" arm will receive a 30-microgram sublingual sufentanil tablet | Drug | SST 30 mcg |
| Standard of Care (SOC)patients randomized in the "SOC" arm will receive analgesic treatment according to the department's internal pain management protocol. | Other | Standard of Care |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
Assessment of patient satisfaction with pain management using a 10-point scale
Time frame: Hour 0 + 180 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farès MOUSTAFA, PR principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sufentanil sublingual 30 mcg tablet in people with Pain Management, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.