Back to resultsJuvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
Primary Purpose
Headache
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lumbar puncture with Quincke-design needles
lumbar puncture with Sprotte-design needles
Sponsored by
About this trial
This is an interventional prevention trial for Headache focused on measuring postlumbar puncture headache, atraumatic needle, Sprotte, Quincke, lumbar puncture, headache, backache
Eligibility Criteria
Inclusion Criteria:
- lumbar puncture necessary for diagnostic reasons
Exclusion Criteria:
- intrathecal instillation at lumbar puncture
- patients in whom severity of disease make it impossible to judge endpoint criteria
Sites / Locations
- University Pediatric HospitalRecruiting
- Klinik für Kinderheilkunde und JugendmedizinRecruiting
Outcomes
Primary Outcome Measures
headache frequency
headache intensity
Secondary Outcome Measures
position dependent-headache frequency
position dependent-headache intensity
backache frequency
backache intensity
practicability of needle designs (multiple punctures necessary?, longer lasting?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00450060
Brief Title
Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
Official Title
Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
Comparison: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
postlumbar puncture headache, atraumatic needle, Sprotte, Quincke, lumbar puncture, headache, backache
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
lumbar puncture with Quincke-design needles
Intervention Type
Device
Intervention Name(s)
lumbar puncture with Sprotte-design needles
Primary Outcome Measure Information:
Title
headache frequency
Title
headache intensity
Secondary Outcome Measure Information:
Title
position dependent-headache frequency
Title
position dependent-headache intensity
Title
backache frequency
Title
backache intensity
Title
practicability of needle designs (multiple punctures necessary?, longer lasting?
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lumbar puncture necessary for diagnostic reasons
Exclusion Criteria:
intrathecal instillation at lumbar puncture
patients in whom severity of disease make it impossible to judge endpoint criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Friedrich Ebinger, DM
Phone
#49-6221-568488
Email
friedrich.ebinger@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich Ebinger, DM
Organizational Affiliation
University Pediatric Hospital Heidelberg
Official's Role
Study Chair
Facility Information:
Facility Name
University Pediatric Hospital
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Friedrich Ebinger, DM
Phone
#49-6221-568488
Email
friedrich.ebinger@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Friedrich Ebinger, DM
Facility Name
Klinik für Kinderheilkunde und Jugendmedizin
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
15173478
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.
Results Reference
background
PubMed Identifier
15037713
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.
Results Reference
background
Learn more about this trial
Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
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