Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 9:42 AM
Study NCT ID:
NCT04608669
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2020-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paracetamol Hypothermia Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2020-10-24', 'studyFirstSubmitQcDate': '2020-10-24', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature variation', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues']}, 'descriptionModule': {'briefSummary': 'Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04608669', 'briefTitle': 'Paracetamol Hypothermia Children', 'organization': {'class': 'OTHER', 'fullName': 'Saint George Hospital'}, 'officialTitle': 'Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': 'SaintgeorgeHh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Temperature comparison', 'interventionNames': ['Drug: Paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No change', 'interventionNames': ['Drug: Paracetamol']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'description': 'Give paracetamol or placebo and compare temperature', 'armGroupLabels': ['No change', 'Temperature comparison']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Saint Georges hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint George Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hazem Kafrouni', 'investigatorAffiliation': 'Saint George Hospital'}}}}