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Management Following Lumbar Puncture In Children

Management Following Lumbar Puncture In Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02590718
Acronym
MFLPIC
Enrollment
200
Registered
2015-10-29
Start date
2015-10-31
Completion date
2016-09-30
Last updated
2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Puncture Complications

Brief summary

The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process (lying without the pillow and fasting water and food for four hours following lumbar puncture), an optimized postoperative management (lying without the pillow for half an hour following lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.

Detailed description

The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of comfortable LP will be established upon completion of this study.

Interventions

PROCEDUREoptimized postoperative management

lying without the pillow for half an hour after lumbar puncture

Sponsors

Beijing Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* children with indications of lumbar puncture; * voluntarily signed the informed consent

Exclusion criteria

* topical anesthetic skin allergies; * skin infection in lumbar puncture site; * severe intracranial hypertension; * unstable vital signs; * coagulopathy; * intracranial hemorrhage and occupying; * low back pain; * headache and low back pain before lumbar puncture; * past headache after lumbar puncture; * mental retardation, neuropsychiatric symptoms; * children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage); * the case with repeated puncture in one operation

Design outcomes

Primary

MeasureTime frame
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc.up to five days postoperation

Secondary

MeasureTime frameDescription
Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.up to four hours postoperation
comfort degreeup to four hours postoperationevaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
whether bad memories exist or notup to four hours postoperationA questionaire about the operation for all parents and children will be investigated.

Contacts

Primary ContactBing Hu, postgraduate
hubing6028@163.com
Backup ContactBing Liu, postgraduate
1191009583@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026