trauma to the lower or upper limb
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the variation in pain rating measured by the verbal numerical scale between T0 and T0+60 minutes | — |
Secondary
| Measure | Time 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