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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00450060
First received: March 19, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Headache
 Device: lumbar puncture with Quincke-design needles
Device: lumbar puncture with Sprotte-design needles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Headache
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • headache frequency
  • headache intensity

Secondary Outcome Measures:
  • position dependent-headache frequency
  • position dependent-headache intensity
  • backache frequency
  • backache intensity
  • practicability of needle designs (multiple punctures necessary?, longer lasting?

Estimated Enrollment: 150
Study Start Date: January 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450060

Contacts
Contact: Friedrich Ebinger, DM #49-6221-568488 friedrich.ebinger@med.uni-heidelberg.de

Locations
Germany
University Pediatric Hospital Recruiting
Heidelberg, Germany, 69120
Contact: Friedrich Ebinger, DM     #49-6221-568488     friedrich.ebinger@med.uni-heidelberg.de    
Principal Investigator: Friedrich Ebinger, DM            
Klinik für Kinderheilkunde und Jugendmedizin Recruiting
Heilbronn, Germany, 74078
Sponsors and Collaborators
University of Heidelberg
Investigators
Study Chair: Friedrich Ebinger, DM University Pediatric Hospital Heidelberg
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00450060     History of Changes
Other Study ID Numbers: PLPH-01/07
Study First Received: March 19, 2007
Last Updated: March 19, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
postlumbar puncture headache
atraumatic needle
Sprotte
Quincke
 lumbar puncture
headache
backache

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013