Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 12:02 PM
Study NCT ID:
NCT00444756
Status:
COMPLETED
Last Update Posted:
2007-03-08
First Post:
2007-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2007-03-07', 'studyFirstSubmitDate': '2007-03-07', 'studyFirstSubmitQcDate': '2007-03-07', 'lastUpdatePostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain scores for the PIV insertion as judged by the patients and the blinded observer.'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measures included patient and blinded observer VAS scores for pain of jet injection, patient and blinded observer scores for anxiety of PIV insertion, nursing satisfaction of placing the PIV with jet injection or ELA-Maxâ, nursing diffi'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['local anesthesia', 'analgesia', 'peripheral IV', 'Local anesthesia prior to peripheral IV insertion'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '18645542', 'type': 'DERIVED', 'citation': 'Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5. doi: 10.1097/PEC.0b013e31816a8d5b.'}]}, 'descriptionModule': {'briefSummary': 'This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral intravenous catheter (PIV) insertion. The researchers hypothesize that the jet injection of lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.', 'detailedDescription': 'A prospective, block-randomized, controlled trial comparing J-Tip jet injection of 1% buffered lidocaine to a 30-minute application of 4% ELA-Max for topical anesthesia in children 8-15 years old presenting to a tertiary care pediatric emergency department for PIV insertion. All subjects recorded self-reported Visual Analogue Scale (VAS) scores for pain at time of enrollment and pain of PIV insertion. Jet injection subjects also recorded pain of jet injection. Subjects were videotaped during jet injection and PIV insertion. Videotapes were reviewed by a single blinded reviewer for observer-reported VAS pain scores for jet injection and PIV insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 8-15 years requiring a PIV as part of their management in the emergency department.\n\nExclusion Criteria:\n\n* Excluded from the study if they reported use of analgesic medication within 6 hours of enrollment,\n* Had a Glasgow Coma Score \\< 15,\n* A baseline screening VAS pain score \\> 20 mm, or\n* A history of skin hypersensitivity or lidocaine allergy,\n* Were incapable of self-reporting a pain score,\n* Had a known neurological condition that alters pain perception,\n* Had methemoglobinemia, or\n* Did not speak or understand English.'}, 'identificationModule': {'nctId': 'NCT00444756', 'briefTitle': 'Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children', 'organization': {'class': 'OTHER', 'fullName': 'Norton Healthcare'}, 'officialTitle': 'Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Peripheral Intravenous Catheterization in Children', 'orgStudyIdInfo': {'id': '622.04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'J-tip jet injection of 1% buffered lidocaine', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Kosair Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'In K Kim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Department of Pediatric Emergency Medicine, Department of Pediatrics, Kosair Children's Hospital, University of Louisville, Louisville, Kentucky"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norton Healthcare', 'class': 'OTHER'}}}}