Hematological Malignancies Clinical Trial
Official title:
Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children
This protocol is a pilot study on standard care. The main goal is to assess the impact of
positioning on lumbar puncture process especially on pain sensitivity in children.
It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period
is one year, and number of inclusions forecasted is about 30. Each patient will have one LP
in a seated position and one in a lying position.
In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are
essential to diseases diagnosis and treatment.
In hematological malignancies, lumbar punctures are particularly frequent as the therapy
processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety,
apprehension leading to an increasing difficulty in the procedure realization.
Two positions are possible to carry out lumbar puncture: seated or lying position.
The main goal of this study is to assess the impact of the child positioning during the
lumbar puncture process in term of pain, anxiety and stress.
This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion
period is 1 year, 30 patients will be included from 2 to 18 years old.
Each patient will have 2 LP one in seated and one in lying position in a specific order
determined by randomization.
All data regarding pain and anxiety will be collected the day of LP. Patients will be re
contacted 48 hours and 15 days after LP procedure in order to evaluate complications such
post-lumbar puncture syndrome or hematoma. The main analysis will be done on
intent-to-treat-analysis basis and will compare pain intensity between the two groups.
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