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

Not Applicable

• Conditions: Headache

• Registration Number: NCT00450060
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 2007-01
• Status Verified: 2007-03
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-19
• Last Update Submitted: 2007-03-19
• Study First Posted: 2007-03-21
• Last Update Posted: 2007-03-21
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
headache frequency
headache intensity

Secondary Outcome Measures

Name	Time	Method
position dependent-headache frequency
position dependent-headache intensity
backache frequency
backache intensity
practicability of needle designs (multiple punctures necessary?, longer lasting?

Trial Locations

Locations (2)

Klinik für Kinderheilkunde und Jugendmedizin; 🇩🇪 Heilbronn, Germany

University Pediatric Hospital; 🇩🇪 Heidelberg, Germany