Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT02454894
Status:
WITHDRAWN
Last Update Posted:
2015-10-29
First Post:
2015-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization 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': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to the reason that not all participants agree to have anesthesia and postoperative management at the same time', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2015-03-13', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy', 'timeFrame': 'up to five days postoperation'}], 'secondaryOutcomes': [{'measure': 'Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.', 'timeFrame': 'up to four hours postoperation'}, {'measure': 'degree of adaptability', 'timeFrame': 'intraoperative', 'description': 'evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale'}, {'measure': 'time of lumbar puncture', 'timeFrame': 'intraoperative'}, {'measure': 'number of puncture', 'timeFrame': 'intraoperative'}, {'measure': 'success rate', 'timeFrame': 'intraoperative'}, {'measure': 'comfort degree', 'timeFrame': 'up to four hours postoperation', 'description': 'evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale'}, {'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 Complications']}, 'descriptionModule': {'briefSummary': 'The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation 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),less postoperative complications and comfortable LP will be anticipated.'}, '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': 'NCT02454894', 'acronym': 'OLPIC', 'briefTitle': 'Optimization Lumbar Puncture In Children', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'Optimization Lumbar Puncture In Children', 'orgStudyIdInfo': {'id': '20150206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'no anesthesia; postoperative management', 'interventionNames': ['Procedure: postoperative management']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2', 'description': 'no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture'}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'surface anesthesia with lidocaine; postoperative management', 'interventionNames': ['Drug: lidocaine', 'Procedure: postoperative management']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture', 'interventionNames': ['Drug: lidocaine']}], 'interventions': [{'name': 'lidocaine', 'type': 'DRUG', 'description': 'surface anesthesia with lidocaine', 'armGroupLabels': ['Group 3', 'Group 4']}, {'name': 'postoperative management', 'type': 'PROCEDURE', 'description': 'lying without the pillow for half an hour after lumbar puncture', 'armGroupLabels': ['Group 1', 'Group 3']}]}, 'contactsLocationsModule': {'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"}}}}