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

NCT ID: NCT00450060

Last Updated: 2007-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-12-31

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.

Conditions

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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lumbar puncture with Quincke-design needles

Intervention Type DEVICE

lumbar puncture with Sprotte-design needles

Intervention Type DEVICE

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Friedrich Ebinger, DM

Role: STUDY_CHAIR

University Pediatric Hospital Heidelberg

Locations

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University Pediatric Hospital

Heidelberg, , Germany

Site Status RECRUITING

Klinik für Kinderheilkunde und Jugendmedizin

Heilbronn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Friedrich Ebinger, DM

Role: CONTACT

#49-6221-568488

Facility Contacts

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Friedrich Ebinger, DM

Role: primary

#49-6221-568488

References

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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.

Reference Type BACKGROUND
PMID: 15173478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15037713 (View on PubMed)

Other Identifiers

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PLPH-01/07

Identifier Type: -

Identifier Source: org_study_id

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