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| Sponsored by: |
Air Liquide Santé International |
|---|---|
| Information provided by: | Air Liquide Santé International |
| ClinicalTrials.gov Identifier: | NCT00643357 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Burns |
Drug: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar) Drug: 50%Oxygen/50% Nitrogen premix |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Study of the Efficacy and Safety of KALINOX® 170 Bar for the Performance of Care Procedures in Children With Burns |
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
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
|
|
B: Placebo Comparator
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
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Exclusion criteria:
Contacts and Locations More Information
| Responsible Party: | Air Liquide Santé International ( peter Onody / Pharmacist and director of medico-marketing department ) |
| Study ID Numbers: | 2006-002698-38 |
| Study First Received: | March 19, 2008 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00643357 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Spain: Spanish Agency of Medicines |
|
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 |
|
Burns Nitrous Oxide Wounds and Injuries Disorders of Environmental Origin |
|
Anesthetics, Inhalation Anesthetics, General Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |
