Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
Recruitment status was Recruiting
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.
Device: lumbar puncture with Quincke-design needles
Device: lumbar puncture with Sprotte-design needles
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs|
- headache frequency
- headache intensity
- position dependent-headache frequency
- position dependent-headache intensity
- backache frequency
- backache intensity
- practicability of needle designs (multiple punctures necessary?, longer lasting?
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450060
|Contact: Friedrich Ebinger, DMfirstname.lastname@example.org|
|University Pediatric Hospital||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Friedrich Ebinger, DM #49-6221-568488 email@example.com|
|Principal Investigator: Friedrich Ebinger, DM|
|Klinik für Kinderheilkunde und Jugendmedizin||Recruiting|
|Heilbronn, Germany, 74078|
|Study Chair:||Friedrich Ebinger, DM||University Pediatric Hospital Heidelberg|