Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT00643357
Eligibility Criteria:
Inclusion Criteria:
* Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
* potentially mildly to moderately painful
* lasting for at least 15 minutes and for less than 30 minutes
* eligible to receive short-term prophylactic analgesic treatment
* for whom the consent form has been signed (parent and child)
Exclusion criteria:
* Child treated under general anaesthesia
* Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.
* Child suffering from moderate to severe pain when beginning the care procedure (FPSr \> 4)
* Exclusion criteria linked to the product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
15 Years
Study:
NCT00643357
Study Brief:
Protocol Section:
NCT00643357