NCT00450060

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 21, 2007

Status Verified

March 1, 2007

First QC Date

March 19, 2007

Last Update Submit

March 19, 2007

Conditions

Headache

Keywords

postlumbar puncture headacheatraumatic needleSprotteQuinckelumbar punctureheadachebackache

Outcome Measures

Primary Outcomes (2)

  • 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?

Interventions

lumbar puncture with Quincke-design needlesDEVICE
lumbar puncture with Sprotte-design needlesDEVICE

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • lumbar puncture necessary for diagnostic reasons

You may not qualify if:

  • intrathecal instillation at lumbar puncture
  • patients in whom severity of disease make it impossible to judge endpoint criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Pediatric Hospital

Heidelberg, 69120, Germany

RECRUITING

Klinik für Kinderheilkunde und Jugendmedizin

Heilbronn, 74078, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15173478BACKGROUND

  • Ebinger 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.

    PMID: 15037713BACKGROUND

MeSH Terms

Conditions

HeadacheBack Pain

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Friedrich Ebinger, DM

    University Pediatric Hospital Heidelberg

    STUDY CHAIR

Central Study Contacts

Friedrich Ebinger, DM

CONTACT

#49-6221-568488friedrich.ebinger@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 21, 2007

Study Start

January 1, 2007

Study Completion

December 1, 2007

Last Updated

March 21, 2007

Record last verified: 2007-03

Locations

DE(2)