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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Heidelberg University.
Recruitment status was:  Recruiting
Information provided by:
Heidelberg University Identifier:
First received: March 19, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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
Intervention Model: Parallel Assignment
Masking: Double
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:

Further study details as provided by Heidelberg University:

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.


Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00450060

Contact: Friedrich Ebinger, DM #49-6221-568488

University Pediatric Hospital Recruiting
Heidelberg, Germany, 69120
Contact: Friedrich Ebinger, DM    #49-6221-568488   
Principal Investigator: Friedrich Ebinger, DM         
Klinik für Kinderheilkunde und Jugendmedizin Recruiting
Heilbronn, Germany, 74078
Sponsors and Collaborators
Heidelberg University
Study Chair: Friedrich Ebinger, DM University Pediatric Hospital Heidelberg
  More Information

Publications: Identifier: NCT00450060     History of Changes
Other Study ID Numbers: PLPH-01/07
Study First Received: March 19, 2007
Last Updated: March 19, 2007

Keywords provided by Heidelberg University:
postlumbar puncture headache
atraumatic needle
lumbar puncture

Additional relevant MeSH terms:
Post-Dural Puncture Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases processed this record on September 21, 2017