Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Heidelberg University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Heidelberg University
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00450060
First received: March 19, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
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.
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| 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
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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 ClinicalTrials.gov identifier: NCT00450060
Please refer to this study by its ClinicalTrials.gov identifier: 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
Publications:
| ClinicalTrials.gov Identifier: | NCT00450060 History of Changes |
| Other Study ID Numbers: | PLPH-01/07 |
| Study First Received: | March 19, 2007 |
| Last Updated: | March 19, 2007 |
| Health Authority: | Germany: Ethics Commission |
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 |
ClinicalTrials.gov processed this record on September 23, 2016