ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00450060
Recruitment Status : Unknown
Verified March 2007 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : March 21, 2007
Last Update Posted : March 21, 2007
Sponsor:
Information provided by:
Heidelberg University

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Headache Device: lumbar puncture with Quincke-design needles Device: lumbar puncture with Sprotte-design needles Not Applicable

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.


Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
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
Study Start Date : January 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. headache frequency
  2. headache intensity

Secondary Outcome Measures :
  1. position dependent-headache frequency
  2. position dependent-headache intensity
  3. backache frequency
  4. backache intensity
  5. practicability of needle designs (multiple punctures necessary?, longer lasting?

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Heidelberg University
Investigators
Study Chair: Friedrich Ebinger, DM University Pediatric Hospital Heidelberg
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00450060     History of Changes
Other Study ID Numbers: PLPH-01/07
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: March 21, 2007
Last Verified: March 2007

Keywords provided by Heidelberg University:
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