Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-27 @ 1:28 PM
Study NCT ID:
NCT00126932
Status:
COMPLETED
Last Update Posted:
2007-12-27
First Post:
2005-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Topical Anesthetic Onset Time Using Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2004-12'}, 'lastUpdateSubmitDate': '2007-12-20', 'studyFirstSubmitDate': '2005-08-03', 'studyFirstSubmitQcDate': '2005-08-03', 'lastUpdatePostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain associated with venipuncture'}], 'secondaryOutcomes': [{'measure': 'safety'}, {'measure': 'skin effects'}, {'measure': 'tolerability'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': "Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 3-7, requiring venipuncture\n\nExclusion Criteria:\n\n* Emergent procedure\n* Allergy to lidocaine or sodium lauryl sulfate'}, 'identificationModule': {'nctId': 'NCT00126932', 'briefTitle': 'Reduction of Topical Anesthetic Onset Time Using Ultrasound', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': 'Reduction of Topical Anesthetic Onset Time Using Ultrasound: A Randomized Controlled Trial Prior to Venipuncture in Young Children', 'orgStudyIdInfo': {'id': '05-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SonoPrep', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "CT Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'William T. Zempsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CT Children's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}}}}