Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:37 AM
Study NCT ID:
NCT00450060
Status:
UNKNOWN
Last Update Posted:
2007-03-21
First Post:
2007-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013129', 'term': 'Spinal Puncture'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-03-19', 'studyFirstSubmitDate': '2007-03-19', 'studyFirstSubmitQcDate': '2007-03-19', 'lastUpdatePostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'headache frequency'}, {'measure': 'headache intensity'}], 'secondaryOutcomes': [{'measure': 'position dependent-headache frequency'}, {'measure': 'position dependent-headache intensity'}, {'measure': 'backache frequency'}, {'measure': 'backache intensity'}, {'measure': 'practicability of needle designs (multiple punctures necessary?, longer lasting?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postlumbar puncture headache', 'atraumatic needle', 'Sprotte', 'Quincke', 'lumbar puncture', 'headache', 'backache'], 'conditions': ['Headache']}, 'referencesModule': {'references': [{'pmid': '15173478', 'type': 'BACKGROUND', 'citation': 'Ebinger F, Kosel C, Pietz J, Rating D. Headache and backache after lumbar puncture in children and adolescents: a prospective study. Pediatrics. 2004 Jun;113(6):1588-92. doi: 10.1542/peds.113.6.1588.'}, {'pmid': '15037713', 'type': 'BACKGROUND', 'citation': 'Ebinger F, Kosel C, Pietz J, Rating D. Strict bed rest following lumbar puncture in children and adolescents is of no benefit. Neurology. 2004 Mar 23;62(6):1003-5. doi: 10.1212/01.wnl.0000115387.67958.0f.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare postlumbar puncture complaints as headache or backache after lumbar puncture with needles with Quincke design or with Sprotte design in children and adolescents.', 'detailedDescription': 'After lumbar puncture patients may develop complaints as position dependent headache, other headache or backache. Several though not all studies in adults showed that the frequency of complaints can be reduced by using non-traumatic Sprotte-design needles instead of cutting Quincke-design needles. In children and adolescents there are no comparable data published. In most pediatric hospitals in Germany Quincke needles are used.\n\nComparison: Children and adolescents from 4 to 18 years of age who have to undergo a lumbar puncture are randomly attributed to puncture with Quincke needle or with Sprotte needle. During the following days headache (main criterium), position-dependent headache, backache, vomitus, and malaise are noted. Pain is measured with a visual analogue scale/faces scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lumbar puncture necessary for diagnostic reasons\n\nExclusion Criteria:\n\n* intrathecal instillation at lumbar puncture\n* patients in whom severity of disease make it impossible to judge endpoint criteria'}, 'identificationModule': {'nctId': 'NCT00450060', 'briefTitle': 'Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs', 'orgStudyIdInfo': {'id': 'PLPH-01/07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lumbar puncture with Quincke-design needles', 'type': 'DEVICE'}, {'name': 'lumbar puncture with Sprotte-design needles', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Friedrich Ebinger, DM', 'role': 'CONTACT', 'email': 'friedrich.ebinger@med.uni-heidelberg.de', 'phone': '#49-6221-568488'}, {'name': 'Friedrich Ebinger, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Pediatric Hospital', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '74078', 'city': 'Heilbronn', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Kinderheilkunde und Jugendmedizin', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}], 'centralContacts': [{'name': 'Friedrich Ebinger, DM', 'role': 'CONTACT', 'email': 'friedrich.ebinger@med.uni-heidelberg.de', 'phone': '#49-6221-568488'}], 'overallOfficials': [{'name': 'Friedrich Ebinger, DM', 'role': 'STUDY_CHAIR', 'affiliation': 'University Pediatric Hospital Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}}}}