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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.
Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2026-01-31
Completion Date
2026-05-01
Last Updated
2026-01-15
Healthy Volunteers
No
Conditions
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.
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.
Locations (2)
Centre Hospitalier Sélestat
Sélestat, Bas-Rhin, France
Hôpital Emile Muller
Mulhouse, Haut-Rhin, France