Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-26 @ 4:58 PM
Study NCT ID:
NCT01188551
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2010-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'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': 'D010880', 'term': 'Piperidines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Joseph.Tobias@nationwidechildrens.org', 'phone': '614-722-4200', 'title': 'Joseph D. Tobias, MD', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine w/ Midazolam', 'description': 'Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fentanyl w/ Midazolam', 'description': 'Midazolam given orally pre-op and fentanyl given intranasally in OR.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dexmedetomidine w/o Midazolam', 'description': 'Dexmedetomidine given intranasally in OR without any pre-medication.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Fentanyl w/o Midazolam', 'description': 'Fentanyl given intranasally in the OR without any pre-medication.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FLACC Behavioral Pain Assessment Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine w/ Midazolam', 'description': 'Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.'}, {'id': 'OG001', 'title': 'Fentanyl w/ Midazolam', 'description': 'Midazolam given orally pre-op and fentanyl given intranasally in OR.'}, {'id': 'OG002', 'title': 'Dexmedetomidine w/o Midazolam', 'description': 'Dexmedetomidine given intranasally in OR without any pre-medication.'}, {'id': 'OG003', 'title': 'Fentanyl w/o Midazolam', 'description': 'Fentanyl given intranasally in the OR without any pre-medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '3', 'spread': '3.60', 'groupId': 'OG001'}, {'value': '1', 'spread': '2.20', 'groupId': 'OG002'}, {'value': '2', 'spread': '2.92', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 mins. post-op', 'description': 'FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.\n\n0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recovery From General Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine w/ Midazolam', 'description': 'Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.'}, {'id': 'OG001', 'title': 'Fentanyl w/ Midazolam', 'description': 'Midazolam given orally pre-op and fentanyl given intranasally in OR.'}, {'id': 'OG002', 'title': 'Dexmedetomidine w/o Midazolam', 'description': 'Dexmedetomidine given intranasally in OR without any pre-medication.'}, {'id': 'OG003', 'title': 'Fentanyl w/o Midazolam', 'description': 'Fentanyl given intranasally in the OR without any pre-medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.67', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '9', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '9.25', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '0.74', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 mins. post-op', 'description': "Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidine w/ Midazolam', 'description': 'Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.'}, {'id': 'FG001', 'title': 'Fentanyl w/ Midazolam', 'description': 'Midazolam given orally pre-op and fentanyl given intranasally in OR.'}, {'id': 'FG002', 'title': 'Dexmedetomidine w/o Midazolam', 'description': 'Dexmedetomidine given intranasally in OR without any pre-medication.'}, {'id': 'FG003', 'title': 'Fentanyl w/o Midazolam', 'description': 'Fentanyl given intranasally in the OR without any pre-medication.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Pharmacy issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients were recruited from the outpatient ENT surgery service at Nationwide Children's Hospital."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine w/ Midazolam', 'description': 'Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.'}, {'id': 'BG001', 'title': 'Fentanyl w/ Midazolam', 'description': 'Midazolam given orally pre-op and fentanyl given intranasally in OR.'}, {'id': 'BG002', 'title': 'Dexmedetomidine w/o Midazolam', 'description': 'Dexmedetomidine given intranasally in OR without any pre-medication.'}, {'id': 'BG003', 'title': 'Fentanyl w/o Midazolam', 'description': 'Fentanyl given intranasally in the OR without any pre-medication.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.14', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '3', 'spread': '2.02', 'groupId': 'BG001'}, {'value': '2.98', 'spread': '1.87', 'groupId': 'BG002'}, {'value': '2.22', 'spread': '1.16', 'groupId': 'BG003'}, {'value': '3', 'spread': '1.59', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2010-08-24', 'resultsFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-17', 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLACC Behavioral Pain Assessment Scale Scores', 'timeFrame': '30 mins. post-op', 'description': 'FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.\n\n0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both'}], 'secondaryOutcomes': [{'measure': 'Recovery From General Anesthesia', 'timeFrame': '30 mins. post-op', 'description': "Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myringotomy', 'pressure equalization tubes'], 'conditions': ['Chronic Otitis Media']}, 'referencesModule': {'references': [{'pmid': '17273114', 'type': 'BACKGROUND', 'citation': 'Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007 Mar;8(2):115-31. doi: 10.1097/01.PCC.0000257100.31779.41.'}, {'pmid': '17646493', 'type': 'BACKGROUND', 'citation': 'Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)\n* patients scheduled for placement of bilateral myringotomy tubes\n\nExclusion Criteria:\n\n* history of allergy to either dexmedetomidine or fentanyl\n* concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.'}, 'identificationModule': {'nctId': 'NCT01188551', 'briefTitle': 'Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl', 'orgStudyIdInfo': {'id': 'IRB10-00377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine w/ midazolam', 'description': 'Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl w/ midazolam', 'description': 'Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.', 'interventionNames': ['Drug: Fentanyl', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine w/o midazolam', 'description': '1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl w/o midazolam', 'description': '1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'dexmedetomidine (1 µg/kg) will be administered intranasally', 'armGroupLabels': ['dexmedetomidine w/ midazolam', 'dexmedetomidine w/o midazolam']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'fentanyl (2 µg/kg) will be administered intranasally', 'armGroupLabels': ['fentanyl w/ midazolam', 'fentanyl w/o midazolam']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Versed'], 'description': 'Sedative given pre-op.', 'armGroupLabels': ['dexmedetomidine w/ midazolam', 'fentanyl w/ midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}