Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-01 @ 6:57 AM
Study NCT ID:
NCT00643357
Status:
WITHDRAWN
Last Update Posted:
2012-01-19
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No patient recruited due to current guidelines for the pain related to burn', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intensity of the pain was assessed using the "Faces Pain Scale Revised"', 'timeFrame': 'Faces Pain Scale Revised'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nCare procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain.\n\nAnalgesia 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care\n\n * potentially mildly to moderately painful\n * lasting for at least 15 minutes and for less than 30 minutes\n * eligible to receive short-term prophylactic analgesic treatment\n * for whom the consent form has been signed (parent and child)\n\nExclusion criteria:\n\n* Child treated under general anaesthesia\n* Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.\n* Child suffering from moderate to severe pain when beginning the care procedure (FPSr \\> 4)\n* Exclusion criteria linked to the product'}, 'identificationModule': {'nctId': 'NCT00643357', 'acronym': 'Burns', 'briefTitle': 'Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns', 'organization': {'class': 'INDUSTRY', 'fullName': 'Air Liquide Santé International'}, 'officialTitle': 'Study of the Efficacy and Safety of KALINOX® 170 Bar for the Performance of Care Procedures in Children With Burns', 'orgStudyIdInfo': {'id': '2006-002698-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '50% Oxygen/50% Nitrous oxide premix (Kalinox® 170 bar)', 'interventionNames': ['Drug: 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': '50%Oxygen/50% Nitrogen premix', 'interventionNames': ['Drug: 50%Oxygen/50% Nitrogen premix']}], 'interventions': [{'name': '50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar)', 'type': 'DRUG', 'description': 'gaz flow between 4 to 15 L/min inhalation between 15 to 60 minutes', 'armGroupLabels': ['A']}, {'name': '50%Oxygen/50% Nitrogen premix', 'type': 'DRUG', 'description': 'inhalation between 15 to 60 minutes gaz flow between 4 to 15 l/min', 'armGroupLabels': ['B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Liquide Santé International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}