Pain
Conditions
Brief summary
Analgesic efficacy will be assessed as changes in pain intensity from baseline using age relevant scoring instruments (FLACC score for ages ≥ 1 year to < 5 years, the Wong-Baker faces scale from ages ≥ 5 years to < 9 years, and the 0-10 Numerical Rating Scale (NRS) from ages 9 and above).
Detailed description
Maximum change in pain intensity within 30 min post IMP administration., Number and proportion of participants that achieve a 30% reduction in pain intensity within 30 min post IMP., Change in pain intensity at 10, 15, 20, 30, 45 and 60 min post IMP., Derived variables such as area under curve (AUC), peak change in pain intensity, and duration of effect will be calculated from the recorded pain assessments., Number of children receiving additional analgesics, as assessed by timepoint.
Interventions
None listed
Sponsors
Cessatech A/S
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgesic efficacy will be assessed as changes in pain intensity from baseline using age relevant scoring instruments (FLACC score for ages ≥ 1 year to < 5 years, the Wong-Baker faces scale from ages ≥ 5 years to < 9 years, and the 0-10 Numerical Rating Scale (NRS) from ages 9 and above). | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum change in pain intensity within 30 min post IMP administration., Number and proportion of participants that achieve a 30% reduction in pain intensity within 30 min post IMP., Change in pain intensity at 10, 15, 20, 30, 45 and 60 min post IMP., Derived variables such as area under curve (AUC), peak change in pain intensity, and duration of effect will be calculated from the recorded pain assessments., Number of children receiving additional analgesics, as assessed by timepoint. | — |
Countries
Spain
Outcome results
None listed