|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00450060 |
|
Date of registration:
|
19/03/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
|
|
Scientific title:
|
Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs |
|
Date of first enrolment:
|
January 2007 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00450060 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Friedrich Ebinger, DM |
|
Address:
|
|
|
Telephone:
|
#49-6221-568488 |
|
Email:
|
friedrich.ebinger@med.uni-heidelberg.de |
|
Affiliation:
|
|
|
|
Name:
|
Friedrich Ebinger, DM |
|
Address:
|
|
|
Telephone:
|
#49-6221-568488 |
|
Email:
|
friedrich.ebinger@med.uni-heidelberg.de |
|
Affiliation:
|
|
|
|
Name:
|
Friedrich Ebinger, DM |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Pediatric Hospital Heidelberg |
|
|
Key inclusion & exclusion 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
Age minimum:
4 Years
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Headache
|
|
Intervention(s)
|
|
Device: lumbar puncture with Quincke-design needles
|
|
Device: lumbar puncture with Sprotte-design needles
|
|
Primary Outcome(s)
|
|
headache frequency
|
|
headache intensity
|
|
Secondary Outcome(s)
|
|
backache frequency
|
|
backache intensity
|
|
position dependent-headache frequency
|
|
position dependent-headache intensity
|
|
practicability of needle designs (multiple punctures necessary?, longer lasting?
|
|
Secondary ID(s)
|
|
PLPH-01/07
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|