EmergenciesPhase 4NCT04137198
Sufentanil Intranasal
A Phase 4 study testing Sufentanil in people with Emergencies and Pain, Acute, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Pain, Acute, Analgesia
- What is being tested?
- Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jan 2020to 1 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more
Who cannot join
- pregnant
- <18 years
- prisoners
- lesions of head, face or abdomen
- no consent given or possible
- pain not scorable
Show all 14Show fewer
- known drug abuse or substitution therapy
- chronic level 3 pain medication
- intake of level 3 < 8 hours
- intoxicated patient
- allergy or intolerance to opiates
- renal or hepatic insufficiency
- < 50kg body weight
- hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Stefano Malinverni, MD contact
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint Pierre
Brussels, 1000
Stefano Malinverni, MD, +3225354051, stefano_malinverni@stpierre-bru.be
About this study
Official title: The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.
Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.
Read the detailed description
In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm.
The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.
Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.
- Conditions
- Emergencies, Pain, Acute, Analgesia, Sufentanil
- Being tested
- Sufentanil
- Keywords
- emergency, pain, analgesia, intranasal, sufentanil
- Medical subject headings
- Emergencies, Acute Pain, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Also called Sufenta Forte
intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | classic analgetic protocol |
| intervention | Experimental | intranasal Sufentanil Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain score
pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)
Measured: 15-20 minutes after first administration of Sufentanil
Secondary outcomes (1)
change in pain score
pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)
Measured: 60 minutes after first administration of Sufentanil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start22 Jan 2020
- Primary completion30 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137198
- Sponsor's protocol ID
- SUFIN002
- Status last verified
- Feb 2021
- First submitted
- 22 Oct 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication all IPD will be made available through researchgate.com profile of backup investigator
Publications
Malinverni S, Kreps B, Lucaccioni T, Bouazza FZ, Bartiaux M, Plumacker A, Pascu A, Youatou Towo P. Effect of intranasal sufentanil on acute post-traumatic pain in the emergency department: a randomised controlled trial. Emerg Med J. 2024 Jan 22;41(2):83-88. doi: 10.1136/emermed-2023-213353.
PubMed 37770120
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.
- ClinicalTrials.gov ID
- NCT04137198
- Acronym / sponsor ID
- SUFIN002
- Conditions
- Emergencies, Pain, Acute, Analgesia, Sufentanil
- Keywords
- emergency, pain, analgesia, intranasal, sufentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 Oct 2019 (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.
Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.
Detailed description
In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm.
The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.
Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized trial
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –classic analgetic protocol |
| intervention | Experimental | Drug: Sufentanilintranasal Sufentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more
Key exclusion criteria (14 listed)
- pregnant
- <18 years
- prisoners
- lesions of head, face or abdomen
- no consent given or possible
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 |
|---|---|---|
| SufentanilAlso: Sufenta Forteintranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses | Drug | intervention |
Primary outcome
change in pain score
Time frame: 15-20 minutes after first administration of Sufentanil
pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)
1 secondary outcome
change in pain score
Time frame: 60 minutes after first administration of Sufentanil
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 37770120Malinverni S, Kreps B, Lucaccioni T, Bouazza FZ, Bartiaux M, Plumacker A, Pascu A, Youatou Towo P. Effect of intranasal sufentanil on acute post-traumatic pain in the emergency department: a randomised controlled trial. Emerg Med J. 2024 Jan 22;41(2):83-88. doi: 10.1136/emermed-2023-213353.
- Individual participant dataSharing planned: Yes. After publication all IPD will be made available through researchgate.com profile of backup investigator
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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. This study is not recruiting at the moment.
Stefano Malinverni, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil in people with Emergencies and Pain, Acute, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 1 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Feb 2021. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernard Kreps, MD (+3225353495, bernard_kreps@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain score (time frame: 15-20 minutes after first administration of Sufentanil). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137198, which also lists 1 linked publication.
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 5 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.