Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-28 @ 2:30 PM
Study NCT ID:
NCT02590705
Status:
UNKNOWN
Last Update Posted:
2015-10-29
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia Lumbar Puncture In Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2015-10-28', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of adaptability', 'timeFrame': 'intraoperative', 'description': 'evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale'}], 'secondaryOutcomes': [{'measure': 'time of lumbar puncture', 'timeFrame': 'intraoperative'}, {'measure': 'number of puncture', 'timeFrame': 'intraoperative'}, {'measure': 'success rate', 'timeFrame': 'intraoperative'}, {'measure': 'whether bad memories exist or not', 'timeFrame': 'up to four hours postoperation', 'description': 'A questionaire about the operation for all parents and children will be investigated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Puncture', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process(no anesthesia), lidocaine surface anesthesia is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.', 'detailedDescription': 'The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP) and comfortable LP will be established upon completion of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with indications of lumbar puncture;\n* voluntarily signed the informed consent\n\nExclusion Criteria:\n\n* topical anesthetic skin allergies;\n* skin infection in lumbar puncture site;\n* severe intracranial hypertension;\n* unstable vital signs;\n* coagulopathy;\n* intracranial hemorrhage and occupying;\n* low back pain;\n* headache and low back pain before lumbar puncture;\n* past headache after lumbar puncture;\n* mental retardation, neuropsychiatric symptoms;\n* children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage);\n* the case with repeated puncture in one operation'}, 'identificationModule': {'nctId': 'NCT02590705', 'acronym': 'ALPIC', 'briefTitle': 'Anesthesia Lumbar Puncture In Children', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'Anesthesia Lumbar Puncture In Children (ALPIC)', 'orgStudyIdInfo': {'id': '20150825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'surface anesthesia with lidocaine', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2', 'description': 'no anesthesia'}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'surface anesthesia with lidocaine', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bing Hu, postgraduate', 'role': 'CONTACT', 'email': 'hubing6028@163.com'}, {'name': 'Bing Liu, postgraduate', 'role': 'CONTACT', 'email': '1191009583@163.com'}], 'overallOfficials': [{'name': 'Gang Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Beijing Childrens' Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician/Professor', 'investigatorFullName': 'Gang Liu', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}