Severe Acute PainSA-URGENCT07344350
A Non-randomised, Non-inferiority Comparative Study of Oral Actiskenan (Morphine Sulfate) Versus Intranasal Sufentanil in the Early Management of Severe Acute Pain in Emergency Departments.
An observational study of Severe Acute Pain, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites in France.
Trial summary
The main objective of this study is to evaluate whether the analgesic protocol combining oral Actiskenan is non-inferior to the protocol combining intranasal Sufentanil for treating severe pain in patients admitted to the emergency department. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Acute Pain
- What is being tested?
- Intranasal Sufentanil and Oral Actiskenan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jan 2026to 1 May 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the emergency departments of Emile Muller Hospital in Mulhouse, France and Sélestat Hospital, France, with a score of 6 or higher on the numerical pain rating scale.
Who may be able to join
- Patient presenting with severe acute pain of medical or traumatic origin at admission, with a score of 6 or higher on the numerical pain rating scale;
- Aged 18 years or older;
- No prior use of WHO step III analgesic before admission;
- Hemodynamic, respiratory, and neurological stability;
- Patient informed about the study and not opposed to participation.
- Non-Inclusion Criteria:
Show all 9Show fewer
- Pain related to exacerbation of chronic and/or neuropathic pain;
- Sickle cell crisis;
- Patient with substance abuse.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Emile Muller
Mulhouse, Haut-Rhin, 68100
Centre Hospitalier Sélestat
Sélestat, Bas-Rhin, 67600
About this study
The main objective of this study is to evaluate whether the analgesic protocol combining oral Actiskenan is non-inferior to the protocol combining intranasal Sufentanil for treating severe pain in patients admitted to the emergency department.
The primary endpoint will be the difference between the numerical pain rating scale score at the initial assessment performed by the triage nurse (baseline) and the numerical pain rating scale score measured 30 minutes after treatment administration.
Read the detailed description
Secondary Objectives:
- To evaluate the non-inferiority of the analgesia protocol combining oral actiskenan compared with the protocol combining intranasal sufentanil, 60 minutes after the initial assessment.
- To describe the adverse effects associated with the analgesia protocols. These will be recorded following initiation of the analgesia protocol and will include nausea/vomiting, respiratory depression, dizziness, and impaired alertness.
Research conduct:
The study will not affect the care provided to patients admitted to the emergency departments of the participating centres. Each department will implement its own pain management protocol in accordance with usual care at that centre (i.e., analgesic protocol combining intranasal sufentanil and paracetamol at Emile Muller Hospital - Mulhouse, France; analgesic protocol combining oral actiskenan and paracetamol at Sélestat Hospital Center).
Digital pain assessments and monitoring of treatment-related adverse effects are already part of routine clinical practice for medical and nursing staff. To collect standardized data on pain assessment and treatment-related adverse effects, medical and nursing staff will complete a data collection form for each patient included in the study.
Patient Information: An information sheet will be provided to each eligible patient upon admission. Data will be collected using the data collection form only if the patient does not object.
Data Collected: Upon admission, and subsequently at 30- and 60-minute intervals, data will be collected on the organizational context (number of patients present in the department and number of admissions per hour), patient characteristics, type of pain (medical or traumatic), concomitant medications received (including morphine titration, analgesics, and anxiolytics), and treatment tolerance (adverse effects).
- Conditions
- Severe Acute Pain
- Being tested
- Intranasal Sufentanil, Oral Actiskenan
- Keywords
- Emergency department, Analgesia, Actiskenan, Sufentanil, Morphine
- Medical subject headings
- Acute Pain, Emergencies, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal SufentanilDrug
The patient receives intranasal sufentanil with an initial dose of 0.30 µg/kg, followed by a second half-dose (0.15 µg/kg) after 10 minutes. If pain relief is inadequate, additional doses may be administered at 15-minute intervals. Sufentanil is combined with oral or slow intravenous paracetamol.
Oral ActiskenanDrug
A 10-mg oral tablet of Actiskenan is administered, in combination with paracetamol. The dose is reduced to 5 mg in patients aged over 85 years.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal sufentanil | Patients admitted to the emergency department of Emile Muller Hospital in Mulhouse, France with a score of 6 or higher on the numerical pain rating scale. Receives: Drug: Intranasal Sufentanil | |
| Oral actiskenan | Patients admitted to the emergency departments of Sélestat Hospital, France, with a score of 6 or higher on the numerical pain rating scale. Receives: Drug: Oral Actiskenan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain rating scale score 30 minutes after analgesic treatment is given
The primary endpoint will be the difference between the numerical pain rating scale score at the initial assessment performed by the triage nurse (baseline) and the numerical pain rating scale score measured 30 minutes after treatment administration.
Measured: 30 minutes after analgesic treatment is given
Secondary outcomes (1)
Numerical Pain rating scale score 60 minutes after analgesic treatment is given
The primary endpoint will be the difference between the numerical pain rating scale score at the initial assessment performed by the triage nurse (baseline) and the numerical pain rating scale score measured 60 minutes after treatment administration.
Measured: 60 minutes after analgesic treatment is given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Why it stopped: Study not carried out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute PainStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344350
- Sponsor's protocol ID
- GHRMSA 1455
- Other IDs
- 2025-A02437-42
- Acronym
- SA-URGE
- Status last verified
- May 2026
- First submitted
- 24 Dec 2025
- Last updated
- 8 May 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomised, Non-inferiority Comparative Study of Oral Actiskenan (Morphine Sulfate) Versus Intranasal Sufentanil in the Early Management of Severe Acute Pain in Emergency Departments.
- ClinicalTrials.gov ID
- NCT07344350
- Acronym / sponsor ID
- SA-URGE / GHRMSA 1455
- Conditions
- Severe Acute Pain
- Keywords
- Emergency department, Analgesia, Actiskenan, Sufentanil, Morphine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not carried out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 15 Jan 2026 (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.
The main objective of this study is to evaluate whether the analgesic protocol combining oral Actiskenan is non-inferior to the protocol combining intranasal Sufentanil for treating severe pain in patients admitted to the emergency department.
The primary endpoint will be the difference between the numerical pain rating scale score at the initial assessment performed by the triage nurse (baseline) and the numerical pain rating scale score measured 30 minutes after treatment administration.
Detailed description
Secondary Objectives:
- To evaluate the non-inferiority of the analgesia protocol combining oral actiskenan compared with the protocol combining intranasal sufentanil, 60 minutes after the initial assessment.
- To describe the adverse effects associated with the analgesia protocols. These will be recorded following initiation of the analgesia protocol and will include nausea/vomiting, respiratory depression, dizziness, and impaired alertness.
Research conduct:
The study will not affect the care provided to patients admitted to the emergency departments of the participating centres. Each department will implement its own pain management protocol in accordance with usual care at that centre (i.e., analgesic protocol combining intranasal sufentanil and paracetamol at Emile Muller Hospital - Mulhouse, France; analgesic protocol combining oral actiskenan and paracetamol at Sélestat Hospital Center).
Digital pain assessments and monitoring of treatment-related adverse effects are already part of routine clinical practice for medical and nursing staff. To collect standardized data on pain assessment and treatment-related adverse effects, medical and nursing staff will complete a data collection form for each patient included in the study.
Patient Information: An information sheet will be provided to each eligible patient upon admission. Data will be collected using the data collection form only if the patient does not object.
Data Collected: Upon admission, and subsequently at 30- and 60-minute intervals, data will be collected on the organizational context (number of patients present in the department and number of admissions per hour), patient characteristics, type of pain (medical or traumatic), concomitant medications received (including morphine titration, analgesics, and anxiolytics), and treatment tolerance (adverse effects).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal sufentanil | – | Drug: Intranasal SufentanilPatients admitted to the emergency department of Emile Muller Hospital in Mulhouse, France with a score of 6 or higher on the numerical pain rating scale. |
| Oral actiskenan | – | Drug: Oral ActiskenanPatients admitted to the emergency departments of Sélestat Hospital, France, with a score of 6 or higher on the numerical pain rating scale. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the emergency departments of Emile Muller Hospital in Mulhouse, France and Sélestat Hospital, France, with a score of 6 or higher on the numerical pain rating scale.
Key inclusion criteria (9 listed)
- Patient presenting with severe acute pain of medical or traumatic origin at admission, with a score of 6 or higher on the numerical pain rating scale;
- Aged 18 years or older;
- No prior use of WHO step III analgesic before admission;
- Hemodynamic, respiratory, and neurological stability;
- Patient informed about the study and not opposed to participation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intranasal SufentanilThe patient receives intranasal sufentanil with an initial dose of 0.30 µg/kg, followed by a second half-dose (0.15 µg/kg) after 10 minutes. If pain relief is inadequate, additional doses may be administered at 15-minute intervals. Sufentanil is combined with oral or slow intravenous paracetamol. | Drug | Intranasal sufentanil |
| Oral ActiskenanA 10-mg oral tablet of Actiskenan is administered, in combination with paracetamol. The dose is reduced to 5 mg in patients aged over 85 years. | Drug | Oral actiskenan |
Primary outcome
Numerical Pain rating scale score 30 minutes after analgesic treatment is given
Time frame: 30 minutes after analgesic treatment is given
The primary endpoint will be the difference between the numerical pain rating scale score at the initial assessment performed by the triage nurse (baseline) and the numerical pain rating scale score measured 30 minutes after treatment administration.
1 secondary outcome
Numerical Pain rating scale score 60 minutes after analgesic treatment is given
Time frame: 60 minutes after analgesic treatment is given
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Pain, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites 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 9 inclusion and 0 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: withdrawn, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain rating scale score 30 minutes after analgesic treatment is given (time frame: 30 minutes after analgesic treatment is given). 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 8 May 2026.