Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01091818
Status:
UNKNOWN
Last Update Posted:
2011-07-21
First Post:
2010-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2010-03-22', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from end of sedation to extubation', 'timeFrame': '1-24 hrs'}]}, 'conditionsModule': {'keywords': ['To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in children', 'treatment'], 'conditions': ['Sedation']}, 'descriptionModule': {'briefSummary': "Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years.\n\nThe investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent from parents\n* age between 2 and 18 years\n* anticipated need of respirator treatment for more than 24 hrs\n* included in study within 48 hrs of admission to intensive care unit (ICU)\n\nExclusion Criteria:\n\n* severe, unstable circulatory failure\n* severe intracranial or spinal trauma with circulatory instability\n* sever bradycardia or atrioventricular (A-V) block\n* liver failure\n* less than 50% chance of anticipated survival\n* known allergy to study drugs'}, 'identificationModule': {'nctId': 'NCT01091818', 'briefTitle': 'Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children', 'orgStudyIdInfo': {'id': 'dexmedetmidazchildintsed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'midazolam', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'dexmedetomidin', 'interventionNames': ['Drug: dexmedetomidine']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Midazolam is given as major sedative drug'], 'description': 'Dexemedethomidine is given as major sedative drug', 'armGroupLabels': ['dexmedetomidin']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Midazolam is given as major sedative drug', 'armGroupLabels': ['midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Johan Rader, PhD', 'role': 'CONTACT', 'email': 'johan.rader@medisin.uio.no', 'phone': '004792249669'}], 'facility': 'Dept of Anesthesiology, Oslo University Hospital, Ullevaal', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Johan Rader/Professor', 'oldOrganization': 'University of Oslo'}}}}