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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.

NCT07344350 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07344350 on ClinicalTrials.gov