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. (SA-URGE)

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Status: Not yet enrolling

Conditions: Severe Acute Pain

Treatments: Drug: Oral Actiskenan; Drug: Intranasal Sufentanil

Study type: Observational

Funder types: Other

Identifiers

NCT07344350

2025-A02437-42 (Other Identifier)

GHRMSA 1455

Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Non-Inclusion Criteria:

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

Trial design

400 participants in 2 patient groups

Intranasal sufentanil

Description:

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.

Treatment:

Drug: Intranasal Sufentanil

Oral actiskenan

Description:

Patients admitted to the emergency departments of Sélestat Hospital, France, with a score of 6 or higher on the numerical pain rating scale.

Treatment:

Drug: Oral Actiskenan