Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT00552695
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2007-10-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lidocaine Patches Prior to Intravenous Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adam.singer@stonybrook.edu', 'phone': '631-444-7857', 'title': 'Adam Singer', 'organization': 'Stony Brook U'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LIDODERM Patch', 'description': 'Lidocaine 70 mg/tetracaine 70 mg skin patch', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Patch', 'description': 'Warm patch with no active substances', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Success of Intravenous (IV) Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LIDODERM Patch', 'description': 'Lidocaine 70 mg/tetracaine 70 mg skin patch'}, {'id': 'OG001', 'title': 'Control Patch', 'description': 'Warm patch with no active substances'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After first attempt of catheter insertion', 'description': 'Percentage of patients in whom intravenous catheter was inserted successfully', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain on Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LIDODERM Patch', 'description': 'Lidocaine 70 mg/tetracaine 70 mg skin patch'}, {'id': 'OG001', 'title': 'Control Patch', 'description': 'Warm patch with no active substances'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '40'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 MINUTES', 'description': 'Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LIDODERM Patch', 'description': 'Lidocaine 70 mg/tetracaine 70 mg skin patch'}, {'id': 'FG001', 'title': 'Control Patch', 'description': 'Warm patch with no active substances'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'August 2007', 'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'August 2007', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'September 2007', 'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'September 2007', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LIDODERM Patch', 'description': 'Lidocaine 70 mg/tetracaine 70 mg skin patch'}, {'id': 'BG001', 'title': 'Control Patch', 'description': 'Warm patch with no active substances'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '10.8', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '10', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-19', 'studyFirstSubmitDate': '2007-10-31', 'resultsFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-05', 'studyFirstPostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on Visual Analog Scale (VAS)', 'timeFrame': '0 MINUTES', 'description': 'Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).'}], 'secondaryOutcomes': [{'measure': 'Success of Intravenous (IV) Insertion', 'timeFrame': 'After first attempt of catheter insertion', 'description': 'Percentage of patients in whom intravenous catheter was inserted successfully'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intravenous catheter', 'emergency department', 'pain'], 'conditions': ['Need for Intravenous Catheter']}, 'descriptionModule': {'briefSummary': 'This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.', 'detailedDescription': 'Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 3,\n* Need for non-emergent intravenous catheter\n\nExclusion Criteria:\n\n* Unstable patients,\n* Allergy to lidocaine or tetracaine'}, 'identificationModule': {'nctId': 'NCT00552695', 'briefTitle': 'Lidocaine Patches Prior to Intravenous Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.', 'orgStudyIdInfo': {'id': '20076689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Lidocaine 70 mg/tetracaine 70 mg skin patch', 'interventionNames': ['Device: Lidocaine tetracaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Lidocaine tetracaine', 'type': 'DEVICE', 'otherNames': ['Synera'], 'description': 'Lidocaine 70 mg/tetracaine 70 mg', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': 'Placebo patch identical in appearance to Synera', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Adam J Singer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Adam Singer', 'investigatorAffiliation': 'Stony Brook University'}}}}