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SubSUF-ER - Management of moderate to severe monotraumatic pain with sublingual Sufentanil in an emergency situation.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519217-64-00
Acronym
RBHP 2024 MOUSTAFA
Enrollment
300
Registered
2025-03-21
Start date
2025-04-22
Completion date
Unknown
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

trauma to the lower or upper limb

Brief summary

the variation in pain rating measured by the verbal numerical scale between T0 and T0+60 minutes

Detailed description

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), 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., Measurement of variations in hemodynamic parameters: blood pressure, pulse, oxygen saturation, respiratory rate., 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

Interventions

DRUGKETOPROFENE AGUETTANT 100 mg
DRUGsolution pour perfusion
DRUGMORPHINE (CHLORHYDRATE) RENAUDIN 10 mg/ml
DRUGsolution injectable
DRUGCODOLIPRANE 500 mg/30 mg
DRUGcomprimé
DRUGIXPRIM 37
DRUG5 mg/325 mg
DRUGcomprimé pelliculé
DRUGKALINOX 50 %/ 50 % Gas zur medizinischen Anwendung
DRUGdruckverdichtet
DRUGgélule

Sponsors

University Hospital Of Clermont-Ferrand
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
the variation in pain rating measured by the verbal numerical scale between T0 and T0+60 minutes

Secondary

MeasureTime frame
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), 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., Measurement of variations in hemodynamic parameters: blood pressure, pulse, oxygen saturation, respiratory rate., 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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026