Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-25 @ 4:00 PM
Study NCT ID:
NCT00533468
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2007-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reingoldj@email.chop.edu', 'phone': '6027516093', 'title': 'Dr James Reingold', 'organization': "Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Significant technical limitation was encountered regarding videotaping of infant faces when properly positioned for the procedure, as the research assistant had to be underneath the nurse's arm with the camera adjacent to the nurse's breast. This resulted in many exclusions of patients enrolled by the male research assistants as the camera was not in proper position. The many exclusions reduced the study's power to reach a statistically significant difference."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients in this arm were administered placebo without active drug', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 10, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Drug', 'description': 'patients in this arm were administered active drug', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neonatal Facial Coding System Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'patients were randomized to placebo in this arm in a double blind fashion'}, {'id': 'OG001', 'title': 'Active Drug', 'description': 'patients were randomized active drug in this arm in a double blind fashion'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.6', 'spread': '4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Positioning', 'categories': [{'measurements': [{'value': '8.3', 'spread': '5', 'groupId': 'OG000'}, {'value': '8', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Pre-needle', 'categories': [{'measurements': [{'value': '7.6', 'spread': '6', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'Needle Insertion', 'categories': [{'measurements': [{'value': '9.3', 'spread': '6', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Post-needle Insertion', 'categories': [{'measurements': [{'value': '5.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'Post-procedure', 'categories': [{'measurements': [{'value': '4.2', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled', 'description': '10 measures of pain, all scored 0 or 1, high score means more pain. No pain would be recorded as zero, maximum pain recorded as 10', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'infants 0-60 days'}, {'type': 'SECONDARY', 'title': 'Time of Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'patients were randomized to placebo in this arm in a double blind fashion'}, {'id': 'OG001', 'title': 'Active Drug', 'description': 'patients were randomized to active drug in this arm in a double blind fashion'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '12', 'groupId': 'OG000'}, {'value': '36', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Infant's stay in the Emergency Department", 'description': "Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'infants 0-60 days of age'}, {'type': 'SECONDARY', 'title': 'Percentage of Procedures With Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'patients were randomized to placebo in this arm in a double blind fashion'}, {'id': 'OG001', 'title': 'Active Drug', 'description': 'patients were randomized to active drug in this arm in a double blind fashion'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "During patient's Emergency Department Stay", 'description': 'Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing', 'unitOfMeasure': 'percentage of procedures', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'patients in this arm were randomized to placebo in a double blind fashion'}, {'id': 'FG001', 'title': 'Active Drug', 'description': 'patients in this arm were randomized to receive the active drug, LMX4, in a double blind fashion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'patients were randomized to placebo or active drug in a double blind fashion'}, {'id': 'BG001', 'title': 'Active Drug', 'description': 'patients were randomized to placebo or active drug in a double blind fashion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.6', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '31.5', 'spread': '15.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'gestational age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '39', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WEIGHT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5094', 'spread': '2147', 'groupId': 'BG000'}, {'value': '4492', 'spread': '1387', 'groupId': 'BG001'}, {'value': '4708', 'spread': '1651', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'GRAMS', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2007-09-19', 'resultsFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2007-09-19', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-28', 'studyFirstPostDateStruct': {'date': '2007-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal Facial Coding System Score', 'timeFrame': 'Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled', 'description': '10 measures of pain, all scored 0 or 1, high score means more pain. No pain would be recorded as zero, maximum pain recorded as 10'}], 'secondaryOutcomes': [{'measure': 'Time of Procedure', 'timeFrame': "Infant's stay in the Emergency Department", 'description': "Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department"}, {'measure': 'Percentage of Procedures With Success', 'timeFrame': "During patient's Emergency Department Stay", 'description': 'Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain', 'lumbar puncture', 'neonates', 'infants', 'emergency department', 'topical anesthesia', 'LMX4'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': "The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).", 'detailedDescription': "Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term (\\>=37 weeks gestation)\n* Age 0-60 Days\n* Undergoing Lumbar Puncture\n\nExclusion Criteria:\n\n* Unstable\n* Premature (\\<37 weeks gestation)\n* Allergy to study medicine\n* Parent refusal of consent'}, 'identificationModule': {'nctId': 'NCT00533468', 'briefTitle': '"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': '"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."', 'orgStudyIdInfo': {'id': '05-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Drug', 'description': 'Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing', 'interventionNames': ['Drug: Lidocaine Cream 4%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Cream made on same run at factory but without active Lidocaine 4% drug', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine Cream 4%', 'type': 'DRUG', 'otherNames': ['LMX4'], 'description': 'Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure', 'armGroupLabels': ['Active Drug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'inactive placebo without LMX4', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "Women's and Children's Hospital of Buffalo", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'James L Reingold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ferndale Laboratories, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'James Reingold', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}