Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs

Conditions
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Headache

Intervention / Treatment
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* Device: lumbar puncture with Quincke-design needles
* Device: lumbar puncture with Sprotte-design needles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: lumbar puncture with Quincke-design needles|nan|
|Device: lumbar puncture with Sprotte-design needles|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| headache frequency |  |  | 
| headache intensity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| position dependent-headache frequency |  |  | 
| position dependent-headache intensity |  |  | 
| backache frequency |  |  | 
| backache intensity |  |  | 
| practicability of needle designs (multiple punctures necessary?, longer lasting? |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postlumbar puncture headache, atraumatic needle, Sprotte, Quincke, lumbar puncture, headache, backache