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NCT00450060 Clinical Trial

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

Headache Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00450060
Other study ID # PLPH-01/07
Secondary ID
Status Recruiting
Phase N/A
First received March 19, 2007
Last updated March 19, 2007
Start date January 2007
Est. completion date December 2007

Study information
Verified date March 2007
Source Heidelberg University
Contact Friedrich Ebinger, DM
Phone #49-6221-568488
Email friedrich.ebinger@med.uni-heidelberg.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 18 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• lumbar puncture with Quincke-design needles

• lumbar puncture with Sprotte-design needles

Locations
Country Name City State
Germany University Pediatric Hospital Heidelberg
Germany Klinik für Kinderheilkunde und Jugendmedizin Heilbronn

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary headache frequency
Primary headache intensity
Secondary position dependent-headache frequency
Secondary position dependent-headache intensity
Secondary backache frequency
Secondary backache intensity
Secondary practicability of needle designs (multiple punctures necessary?, longer lasting?
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