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

January 18, 2012 updated by: Air Liquide Santé International

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar)
Drug: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)
gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes
Placebo Comparator: B
50%Oxygen/50% Nitrogen premix
Drug: 50%Oxygen/50% Nitrogen premix
inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The intensity of the pain was assessed using the "Faces Pain Scale Revised"
Time Frame: Faces Pain Scale Revised
Faces Pain Scale Revised

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Liquide Santé International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-002698-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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