HeadacheNCT00450060
Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
A study testing lumbar puncture with Quincke-design needles and lumbar puncture with Sprotte-design needles in people with Headache, run by Heidelberg University at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Headache
- What is being tested?
- lumbar puncture with Quincke-design needles and lumbar puncture with Sprotte-design needles
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- lumbar puncture necessary for diagnostic reasons
Who cannot join
- intrathecal instillation at lumbar puncture
- patients in whom severity of disease make it impossible to judge endpoint criteria
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Pediatric Hospital
Heidelberg, 69120
Friedrich Ebinger, DM, #49-6221-568488, friedrich.ebinger@med.uni-heidelberg.de
Friedrich Ebinger, DM
- Recruiting
Klinik für Kinderheilkunde und Jugendmedizin
Heilbronn, 74078
About this study
Official title: Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs
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.
Read the 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.
- Conditions
- Headache
- Being tested
- lumbar puncture with Quincke-design needles, lumbar puncture with Sprotte-design needles
- Keywords
- postlumbar puncture headache, atraumatic needle, Sprotte, Quincke, lumbar puncture, headache, backache
- Medical subject headings
- Headache, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar puncture with Quincke-design needlesDevice
lumbar puncture with Sprotte-design needlesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
headache frequency
headache intensity
Secondary outcomes (5)
position dependent-headache frequency
position dependent-headache intensity
backache frequency
backache intensity
practicability of needle designs (multiple punctures necessary?, longer lasting?
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startJan 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Friedrich Ebinger, DM, Study chair, University Pediatric Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450060
- Sponsor's protocol ID
- PLPH-01/07
- Status last verified
- Mar 2007
- First submitted
- 19 Mar 2007
- Last updated
- 21 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Ebinger F, Kosel C, Pietz J, Rating D. Headache and backache after lumbar puncture in children and adolescents: a prospective study. Pediatrics. 2004 Jun;113(6):1588-92. doi: 10.1542/peds.113.6.1588.
PubMed 15173478Ebinger F, Kosel C, Pietz J, Rating D. Strict bed rest following lumbar puncture in children and adolescents is of no benefit. Neurology. 2004 Mar 23;62(6):1003-5. doi: 10.1212/01.wnl.0000115387.67958.0f.
PubMed 15037713
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs
- ClinicalTrials.gov ID
- NCT00450060
- Acronym / sponsor ID
- PLPH-01/07
- Conditions
- Headache
- Keywords
- postlumbar puncture headache, atraumatic needle, Sprotte, Quincke, lumbar puncture, headache, backache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 21 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- lumbar puncture necessary for diagnostic reasons
Key exclusion criteria (2 listed)
- intrathecal instillation at lumbar puncture
- patients in whom severity of disease make it impossible to judge endpoint criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar puncture with Quincke-design needles | Device | – |
| lumbar puncture with Sprotte-design needles | Device | – |
Primary outcome
headache frequency
headache intensity
5 secondary outcomes
position dependent-headache frequency
position dependent-headache intensity
backache frequency
backache intensity
practicability of needle designs (multiple punctures necessary?, longer lasting?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2007.
- Background: PubMed 15173478Ebinger F, Kosel C, Pietz J, Rating D. Headache and backache after lumbar puncture in children and adolescents: a prospective study. Pediatrics. 2004 Jun;113(6):1588-92. doi: 10.1542/peds.113.6.1588.
- Background: PubMed 15037713Ebinger F, Kosel C, Pietz J, Rating D. Strict bed rest following lumbar puncture in children and adolescents is of no benefit. Neurology. 2004 Mar 23;62(6):1003-5. doi: 10.1212/01.wnl.0000115387.67958.0f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedrich Ebinger, DM study chair
University Pediatric Hospital Heidelberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar puncture with Quincke-design needles and lumbar puncture with Sprotte-design needles in people with Headache, run by Heidelberg University at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Friedrich Ebinger, DM (#49-6221-568488, friedrich.ebinger@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
headache frequency. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00450060, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2007.