Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 5:08 PM
Study NCT ID:
NCT00765934
Status:
COMPLETED
Last Update Posted:
2010-05-18
First Post:
2008-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Rapydan on Clinical Chemistry and Hematology Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-17', 'studyFirstSubmitDate': '2008-10-02', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Routine Clinical Chemistry measurements differences', 'timeFrame': '1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '17716323', 'type': 'BACKGROUND', 'citation': 'Curry SE, Finkel JC. Use of the Synera patch for local anesthesia before vascular access procedures: a randomized, double-blind, placebo-controlled study. Pain Med. 2007 Sep;8(6):497-502. doi: 10.1111/j.1526-4637.2006.00204.x.'}, {'pmid': '1815978', 'type': 'BACKGROUND', 'citation': 'Amdisen A, Glud V. No influence from topical application of EMLA cream before blood sampling on routine clinical chemistry and haematology measurements. Eur J Clin Pharmacol. 1991;41(6):619-20. doi: 10.1007/BF00314997.'}]}, 'descriptionModule': {'briefSummary': 'There is an increasing awareness of the importance of treating procedure-related pain. Patients undergoing vascular access procedures are often afraid of needles and the discomfort associated with injections. This type of pain and/or fear can be stressful to patients. \\[1\\] For prevention of the pain associated with these procedures, the hospital is using Rapydan plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan produces topical anesthesia after an application time of 30 minutes and is used in the Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood draining the anaesthetized skin contains a higher blood concentration of the local anesthetics than does venous blood in other parts of the body \\[2\\] Although the concentrations of the local anesthetics are low in patients with normal skin, the question is whether the presence of the local anesthetics which Rapydan contains might influence routine measurements in clinical chemistry and hematology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVolunteers 20-60 years who are decision making competent\n\nExclusion Criteria:\n\nPatients with local anesthetic allergy Patients using antiarrhythmic drugs Patients using other local anesthetics'}, 'identificationModule': {'nctId': 'NCT00765934', 'briefTitle': 'Influence of Rapydan on Clinical Chemistry and Hematology Measurements', 'organization': {'class': 'OTHER', 'fullName': 'LabNoord'}, 'officialTitle': 'Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?', 'orgStudyIdInfo': {'id': 'RapydanClinicalChemistry'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Rapydan', 'description': 'Internal control. Blood from both arms will be drawn. Only one arm of the subject is treated with Rapydan.', 'interventionNames': ['Drug: Rapydan']}], 'interventions': [{'name': 'Rapydan', 'type': 'DRUG', 'otherNames': ['Lidocaine Tetracaine Patch'], 'description': 'lidocaine / tetracaine 70/70 mg patch', 'armGroupLabels': ['Rapydan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'LabNoord', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Rob Oude Elferink, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LabNoord'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LabNoord', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'R.F.M. Oude Elferink', 'oldOrganization': 'LabNoord'}}}}