Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns

• Status: Withdrawn
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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, Tunisia and Belgium) study with 8 investigator centers.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Liquide Santé International
• Treatments: Nitrous Oxide

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