Impact of Child Positioning on Pain During a Lumbar Puncture

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children

Conditions
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Hematological Malignancies

Intervention / Treatment
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* Other: LP in a seated position then LP in a lying position
* Other: LP in a lying position then LP in a seated position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LP in a seated position then LP in a lying position<br>Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position | Other: LP in a seated position then LP in a lying position<br> <br> |
| Other: LP in a lying position then LP in a seated position<br>Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position | Other: LP in a lying position then LP in a seated position<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensitivity during the lumbar puncture procedure. | It will be evaluated throw specific pain assessment scales according to patient age | duration of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |