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.

NCT07344350 | Not Yet Recruiting

• 2 other identifiers: GHRMSA 14552025-A02437-42
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Severe Acute Pain

Keywords

Emergency department; Analgesia; Actiskenan; Sufentanil; Morphine

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes after analgesic treatment is given

Secondary Outcomes (1)

• Numerical Pain rating scale score 60 minutes after analgesic treatment is given

  60 minutes after analgesic treatment is given

Study Arms (2)

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.

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.

Drug: Oral Actiskenan

Interventions

Intranasal Sufentanil DRUG

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.

Intranasal sufentanil

Oral Actiskenan DRUG

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.

Oral actiskenan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• Pain related to exacerbation of chronic and/or neuropathic pain;
• Sickle cell crisis;
• Patient with substance abuse.

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (2)

Centre Hospitalier Sélestat

Sélestat, Bas-Rhin, 67600, France

Location

Hôpital Emile Muller

Mulhouse, Haut-Rhin, 68100, France

Location

MeSH Terms

Conditions

Acute Pain; Emergencies; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Léa Feuillassier, MD

CONTACT

+33389646464; lea.feuillassier@ghrmsa.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 15, 2026
• Study Start: January 31, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)