Hematological Malignancies
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERLP in a seated position then LP in a lying position
OTHERLP in a lying position then LP in a seated position
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age between 2 and 18 years old * Patients requiring at least 2 therapeutic lumbar punctures * Patients able to receive analgesic procedure according to 20005 good practices recommendation * Presence of one parent during LP procedure * Child able to use assessment scales * LP realized with a 20 G needle * Platelets \> 50000 * Child with prior clinical examination * Affiliated to a health care insurance regimen
Exclusion criteria
* Seated or lying position impossible * Lumbar puncture contraindication * Patient or parent opposition to second LP realization in the required position * Clotting trouble on LP day not allowing the LP procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain sensitivity during the lumbar puncture procedure. | duration of the procedure | It will be evaluated throw specific pain assessment scales according to patient age |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety during the lumbar puncture procedure on a scale of one to ten | duration of the procedure |
| Time of the lumbar puncture procedure | duration of the procedure |
Countries
France
Outcome results
None listed