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
|Condition or disease||Intervention/treatment||Phase|
|Headache||Device: lumbar puncture with Quincke-design needles Device: lumbar puncture with Sprotte-design needles||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|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|
- 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?
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
|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|