Non-traumatic pain
Conditions
Brief summary
The primary endpoint will be pain assessed using the Visual Analog Scale (VAS). The VAS is a simple pain assessment tool consisting of marking a point on a color-graded ruler calibrated in millimeters, allowing pain intensity to be assigned a numerical value ranging from 0 (no pain) to 100 mm (unbearable pain). Pain will be assessed at inclusion, at 3 minutes post-randomization, and then at 5, 10, 15, 20, 25, and 30 minutes using self-administered questionnaires.
Detailed description
Time to onset of pain relief within the first 30 minutes.Measurement of VAS over the first 30 minutes, Pain measured again using the VAS at 60, 90, and 120 minutes post-randomization via self-administered questionnaires., The need for rescue analgesic treatment of any class due to insufficient pain relief or pain recurrence., Adverse events and serious adverse events reported in each group.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be pain assessed using the Visual Analog Scale (VAS). The VAS is a simple pain assessment tool consisting of marking a point on a color-graded ruler calibrated in millimeters, allowing pain intensity to be assigned a numerical value ranging from 0 (no pain) to 100 mm (unbearable pain). Pain will be assessed at inclusion, at 3 minutes post-randomization, and then at 5, 10, 15, 20, 25, and 30 minutes using self-administered questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of pain relief within the first 30 minutes.Measurement of VAS over the first 30 minutes, Pain measured again using the VAS at 60, 90, and 120 minutes post-randomization via self-administered questionnaires., The need for rescue analgesic treatment of any class due to insufficient pain relief or pain recurrence., Adverse events and serious adverse events reported in each group. | — |