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.

NCT ID: NCT07344350

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-05-01

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.

Detailed Description

Secondary Objectives:

1. 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.

2. 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Intranasal Sufentanil

Intervention Type: 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.

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.

Oral Actiskenan

Intervention Type: 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.

Interventions

Intranasal Sufentanil

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.

Intervention Type: DRUG

Oral Actiskenan

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Sélestat

Sélestat, Bas-Rhin, France

Hôpital Emile Muller

Mulhouse, Haut-Rhin, France

Countries

France

Central Contacts

Léa Feuillassier, MD

Role: CONTACT

lea.feuillassier@ghrmsa.fr

+33389646464

Facility Contacts

Mathieu Oberlin, MD

Role: primary

mathieu.oberlin@ghso.fr

+33388575555

Léa Feuillassier, MD

Role: primary

lea.feuillassier@ghrmsa.fr

+33389646464

Other Identifiers

2025-A02437-42

Identifier Type: OTHER

Identifier Source: secondary_id

GHRMSA 1455

Identifier Type: -

Identifier Source: org_study_id