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

NCT ID: NCT00643357

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-01-31

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, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes

B

50%Oxygen/50% Nitrogen premix

Group Type: PLACEBO_COMPARATOR

50%Oxygen/50% Nitrogen premix

Intervention Type: DRUG

inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min

Interventions

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

gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes

Intervention Type: DRUG

50%Oxygen/50% Nitrogen premix

inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min

Intervention Type: DRUG

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Liquide Santé International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2006-002698-38

Identifier Type: -

Identifier Source: org_study_id