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

Air Liquide

Status and phase

Withdrawn

Phase 3

Conditions

Burns

Treatments

Drug: 50%Oxygen/50% Nitrogen premix

Drug: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00643357

2006-002698-38

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

4 to 15 years old

Volunteers

No Healthy Volunteers

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