NCT00643357

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 4 Years – 15 Years
• Healthy volunteers: Not accepted

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.

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 procedures or burn-care procedures. Care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain. Analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. This gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery. The nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years. The objective of our study is to obtain qualitative and quantitative data about the efficacy of Kalinox® 170 bar in care procedures in children with burns.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)	gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes
DRUG	50%Oxygen/50% Nitrogen premix	inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-03-26
• Last updated: 2012-01-19