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

H

Heidelberg University

Status

Unknown

Conditions

Headache

Treatments

Device: lumbar puncture with Quincke-design needles
Device: lumbar puncture with Sprotte-design needles

Study type

Interventional

Funder types

Other

Identifiers

NCT00450060
PLPH-01/07

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

2

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Central trial contact

Friedrich Ebinger, DM

Data sourced from clinicaltrials.gov

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