Status:
WITHDRAWN
Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns
Lead Sponsor:
Air Liquide Santé International
Conditions:
Burns
Eligibility:
All Genders
4-15 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tuni...
Detailed Description
Pain due to burns is one of the most intense and persistent types of pain. This pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment pro...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00643357
Start Date
March 1 2008
End Date
January 1 2009
Last Update
January 19 2012
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