Back to resultsStudy of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns (Burns)
Primary Purpose
Burns
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)
50%Oxygen/50% Nitrogen premix
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring children with burns, Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
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)
- Exclusion criteria linked to the product
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar)
50%Oxygen/50% Nitrogen premix
Outcomes
Primary Outcome Measures
The intensity of the pain was assessed using the "Faces Pain Scale Revised"
Secondary Outcome Measures
Full Information
NCT ID
NCT00643357
First Posted
March 19, 2008
Last Updated
January 18, 2012
Sponsor
Air Liquide Santé International
1. Study Identification
Unique Protocol Identification Number
NCT00643357
Brief Title
Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns
Acronym
Burns
Official Title
Study of the Efficacy and Safety of KALINOX® 170 Bar for the Performance of Care Procedures in Children With Burns
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No patient recruited due to current guidelines for the pain related to burn
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
children with burns, Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
50%Oxygen/50% Nitrogen premix
Intervention Type
Drug
Intervention Name(s)
50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)
Intervention Description
gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes
Intervention Type
Drug
Intervention Name(s)
50%Oxygen/50% Nitrogen premix
Intervention Description
inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min
Primary Outcome Measure Information:
Title
The intensity of the pain was assessed using the "Faces Pain Scale Revised"
Time Frame
Faces Pain Scale Revised
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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)
Exclusion criteria linked to the product
12. IPD Sharing Statement
Learn more about this trial
Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns
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