Post dural puncture headache in children - retrospective, single-center study of prevalence via chart review and questionnaire

• Conditions: G97.0; Cerebrospinal fluid leak from spinal puncture

• Registration Number: DRKS00015862
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-25
• Study Completion: 2020-10-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Age between 4 and 25 years at the time of the lumbar puncture
- lumbar puncture performed between February 2016 and February 2018 at the Zentrum für Kinder- und Jugendmedizin Freiburg

Exclusion Criteria

- oncological diagnosis at the time of lumbar puncture
- clouding of consciousness at the time of lumbar puncture or in the following 72h

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- assessment of the prevalence of PDPH (as defined by IHS) within 72h after lumbar puncture<br>- case number calculation for subsequent planned multicenter AMG (German medicinal products act) study

Secondary Outcome Measures

Name	Time	Method
- recording the occurrence of additional symptoms (nausea, vomiting, impaired vision)<br>- recording the onset and duration of symptoms<br>- determination of the intensity of pain on VAS scale (as far as recallable)<br>- determination of the necessity of hospitalization (incl. length of stay)<br>- determination of the necessity of an epidural blood patch<br>- subgroup analysis of patients with spinal muscular atrophy (SMA) type I, II and III who undergo regular therapeutic lumbar punctures for intrathecal Nusinersen (©Spinraza) and comparison with normal pediatric cohort