Clinical trial • Not applicable • Musculoskeletal|Other

Sufentanil for Traumatic limb injury|Pain in limb

Not applicable trial of Sufentanil for Traumatic limb injury|Pain in limb.

Overview

Trial Therapeutic Area: Musculoskeletal|Other
Trial Disease: Traumatic limb injury|Pain in limb
Trial Stage: Not applicable
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 13-11-2024
First CTIS Authorization Date: 21-03-2025

Trial design

Randomised, open-label, multiple standard-of-care comparator options are listed and may be used per local standard management: paracetamol aguettant 10 mg/ml (intravenous infusion, paracetamol, max total 4 g/day), codoliprane 500 mg/30 mg (oral tablet; paracetamol + codeine), morphine (chlorhydrate) 10 mg/ml (injectable, morphine), kalinox (50%/50% nitrous oxide/oxygen gas, inhalation), ketoprofene 100 mg (iv infusion), acupan 20 mg/2 ml (nefopam iv), tramadol arrow 100 mg/2 ml (injectable tramadol), doliprane 500 mg and 1000 mg (oral paracetamol), ixprim (tramadol/paracetamol). doses and max daily amounts are those listed in product entries (e.g. paracetamol iv max total 4 g/day; sufentanil product labeled 30 µg per tablet with max daily 90 µg). management and choice of comparator follow local standard-care protocol at ed.-controlled Not applicable trial across 1 site in France.

Randomised: Yes
Open Label: Yes
Comparator: Multiple standard-of-care comparator options are listed and may be used per local standard management: PARACETAMOL AGUETTANT 10 mg/ml (intravenous infusion, paracetamol, max total 4 g/day), CODOLIPRANE 500 mg/30 mg (oral tablet; paracetamol + codeine), MORPHINE (chlorhydrate) 10 mg/ml (injectable, morphine), KALINOX (50%/50% nitrous oxide/oxygen gas, inhalation), KETOPROFENE 100 mg (IV infusion), ACUPAN 20 mg/2 mL (nefopam IV), TRAMADOL ARROW 100 mg/2 mL (injectable tramadol), DOLIPRANE 500 mg and 1000 mg (oral paracetamol), IXPRIM (tramadol/paracetamol). Doses and max daily amounts are those listed in product entries (e.g. paracetamol IV max total 4 g/day; sufentanil product labeled 30 µg per tablet with max daily 90 µg). Management and choice of comparator follow local standard-care protocol at ED.
Target Sample Size: 300
Trial Duration For Participant: 0.125

Eligibility

Recruits 300 Vulnerable populations are excluded: "Patient under guardianship, curatorship, deprived of liberty or under legal protection". The trial enrolls adult patients only; consent is to be provided by the patient. Patients who do not speak or read French are excluded..

Pregnancy Exclusion: Woman of childbearing age not using effective contraception, or declaring herself pregnant or at risk of pregnancy or breastfeeding woman, or positive pregnancy test upon inclusion
Vulnerable Population: Vulnerable populations are excluded: "Patient under guardianship, curatorship, deprived of liberty or under legal protection". The trial enrolls adult patients only; consent is to be provided by the patient. Patients who do not speak or read French are excluded.

Inclusion criteria

{"criterion_text":"- adult patient\n- Patient with a numeric pain rating scale ≥ 4\n- Pain of monotraumatic origin in the upper or lower limb\n- Glasgow = 15\n- SaO2 > 95% in ambient air"}

Exclusion criteria

{"criterion_text":"- Polytrauma\n- Patient under guardianship, curatorship, deprived of liberty or under legal protection\n- Patient does not speak or read French\n- Analgesic treatment within 4 hours prior to admission (except paracetamol)\n- Woman of childbearing age not using effective contraception, or declaring herself pregnant or at risk of pregnancy or breastfeeding woman, or positive pregnancy test upon inclusion\n- Patient requiring intravenous line placement upon admission\n- Contraindication or allergy to one of the molecules in the analgesic protocol\n- Refusal to participate\n- Known drug abuse or psychiatric disorders\n- Known oxygen dependency or COPD\n- Not affiliated with social security"}

Endpoints

Primary endpoints

{"endpoint_text":"- the variation in pain rating measured by the verbal numerical scale between T0 and T0+60 minutes","definition_or_measurement_approach":"Change in pain intensity measured by the verbal numerical scale (VNS) between baseline (T0) and T0+60 minutes."}

Secondary endpoints

{"endpoint_text":"- The tolerance profile will be assessed by analyzing the occurrence of any adverse event, mainly (hypotension, bradycardia, respiratory depression, sweating, drowsiness, nausea and/or vomiting, dizziness)","definition_or_measurement_approach":"Assessment and comparison of occurrence of listed adverse events between randomization groups."}
{"endpoint_text":"- Variation of pain rating measured by verbal numerical scale between T0 and T0+15min; T0+30 min; T0+45 min; T0 + 60 min T0+120 min; T0+180 minutes, Variation of pain rating measured by verbal numerical scale between T0 and TEVmax. Pain intensity assessed at different times, T0, T0 + 15min, T0 + 30min, T0 + 45min, T0 + 60min, T0 + 120min, T0 + 180min.","definition_or_measurement_approach":"Repeated measures of pain intensity using the verbal numerical scale at specified timepoints (T0, T0+15, +30, +45, +60, +120, +180 minutes) and comparison between groups."}
{"endpoint_text":"- Measurement of variations in hemodynamic parameters: blood pressure, pulse, oxygen saturation, respiratory rate.","definition_or_measurement_approach":"Serial measurement of vital signs (BP, pulse, SpO2, respiratory rate) and comparison between randomization groups."}
{"endpoint_text":"- At the end of the study at T0 + 180 min, patients will be asked to give their assessment via a verbal satisfaction scale ranging from 0 \"Very dissatisfied\" to 10 \"Very satisfied\": - of the permucosal product tested using a product assessment questionnaire. - Of the pain management in general","definition_or_measurement_approach":"Patient-reported satisfaction assessed at T0+180 minutes using a 0–10 verbal satisfaction scale and a product assessment questionnaire."}

Recruitment

Planned Sample Size: 300
Recruitment Window Months: 12
Consent Approach: Informed consent obtained from the adult patient. Subject information and informed consent form (L1_SIS AND ICF PATIENT) provided; patients who do not speak or read French are excluded. Vulnerable adults under guardianship/curatorship or deprived of liberty are excluded.

Methods

Recruitment of adult patients presenting to the Emergency Department (Service d’Accueil des Urgences) with moderate-to-severe monotraumatic limb pain; identification at admission/triage and inclusion by ED clinical staff (infirmière d’orientation et d’accueil / emergency clinicians) in France (site: University Hospital Of Clermont-Ferrand).

Geography

Total Number Of Sites: 1
Total Number Of Participants: 300

France

Earliest CTIS Part Ii Submission Date: 14-02-2025
Latest Decision Or Authorization Date: 24-04-2026
Processing Time Days: 434
Number Of Sites: 1
Number Of Participants: 300

Sites

Site Name: University Hospital Of Clermont-Ferrand
Department Name: SAMU - SMUR Urgences
Contact Person Name: Farès MOUSTAFA
Contact Person Email: fmoustafa@chu-clermontferrand.fr
Number Of Participants: 300

Sponsor

Primary sponsor

Full Name: University Hospital Of Clermont-Ferrand
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: France

Investigational products

Investigational Product Name: Dzuveo 30 micrograms sublingual tablet
Active Substance: Sufentanil
Modality: Small molecule
Routes Of Administration: Sublingual (oral)
Route: Sublingual
Authorisation Status: Authorised (marketing authorisation EU)
Starting Dose: 30 micrograms
Dose Levels: 30 micrograms (single dose used in study)
Frequency: Single dose at inclusion (per protocol timing at T0)
Maximum Dose: Maximum total per day 90 micrograms (product listing)

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