Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-28 @ 1:18 PM
Study NCT ID:
NCT01255904
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2010-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002697', 'term': 'Chloral Hydrate'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmreynol@bcm.edu', 'phone': '(210) 704-2680', 'title': 'Jason Reynolds', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was not designed to detect small differences in rare adverse and the overall safety of either medication cannot be assessed based on these results alone.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Placebo and Intransal Dexmedetomidine', 'otherNumAtRisk': 44, 'otherNumAffected': 2, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oral Chloral Hydrate and Intranasal Placebo', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild hypoxia < 94% and > 90%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'partial airway obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Complete Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Placebo and Intransal Dexmedetomidine'}, {'id': 'OG001', 'title': 'Oral Chloral Hydrate and Intranasal Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '110'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '119'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60-180 minutes', 'description': 'Time from medication administration to study completion.', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Placebo and Intransal Dexmedetomidine', 'description': 'Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).'}, {'id': 'FG001', 'title': 'Oral Chloral Hydrate and Intranasal Placebo', 'description': '50 mg/kg oral chloral hydrate followed by intranasal placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Placebo and Intransal Dexmedetomidine'}, {'id': 'BG001', 'title': 'Oral Chloral Hydrate and Intranasal Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.33', 'spread': '12.63', 'groupId': 'BG000'}, {'value': '25.55', 'spread': '11.21', 'groupId': 'BG001'}, {'value': '24.40', 'spread': '11.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2010-11-18', 'resultsFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2010-12-07', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-25', 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Complete Study', 'timeFrame': '60-180 minutes', 'description': 'Time from medication administration to study completion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sedation']}, 'referencesModule': {'references': [{'pmid': '34397100', 'type': 'DERIVED', 'citation': 'Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.\n\nExclusion Criteria:\n\n* Patients younger than 6 months or older than 8 years\n* Previously failed sedation\n* Weight greater than 25 kg\n* Weight less than 5 kg\n* BMI above 30\n* Diagnosis of ADHD\n* Any patient deemed inappropriate for nurse administered sedation\n* Patients with any cardiac disease\n* Obstructive sleep apnea'}, 'identificationModule': {'nctId': 'NCT01255904', 'briefTitle': 'A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.', 'orgStudyIdInfo': {'id': 'H-27453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Oral Chloral and intranasal placebo', 'interventionNames': ['Drug: Chloral Hydrate', 'Other: Intranasal placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'oral placebo and intranasal dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine', 'Other: Oral placebo']}], 'interventions': [{'name': 'Chloral Hydrate', 'type': 'DRUG', 'description': 'Oral chloral hydrate 50 mg/kg', 'armGroupLabels': ['Arm 1']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Intranasal dexmedetomidine 3 mcg/kg', 'armGroupLabels': ['Arm 2']}, {'name': 'Oral placebo', 'type': 'OTHER', 'description': 'Oral saline administered', 'armGroupLabels': ['Arm 2']}, {'name': 'Intranasal placebo', 'type': 'OTHER', 'description': 'Intranasal saline administered', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Childrens Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Jason Reynolds', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}