Impact of Child Positioning on Pain During a Lumbar Puncture (PHIPA-PEPL)
Primary Purpose
Hematological Malignancies
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LP in a seated position then LP in a lying position
LP in a lying position then LP in a seated position
Sponsored by
About this trial
This is an interventional other trial for Hematological Malignancies
Eligibility Criteria
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
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LP in a seated position then LP in a lying position
LP in a lying position then LP in a seated position
Arm Description
Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position
Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position
Outcomes
Primary Outcome Measures
Pain sensitivity during the lumbar puncture procedure.
It will be evaluated throw specific pain assessment scales according to patient age
Secondary Outcome Measures
Anxiety during the lumbar puncture procedure on a scale of one to ten
Time of the lumbar puncture procedure
Full Information
NCT ID
NCT02834156
First Posted
July 8, 2016
Last Updated
March 8, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02834156
Brief Title
Impact of Child Positioning on Pain During a Lumbar Puncture
Acronym
PHIPA-PEPL
Official Title
Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 30, 2015 (Actual)
Primary Completion Date
August 23, 2017 (Actual)
Study Completion Date
August 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LP in a seated position then LP in a lying position
Arm Type
Other
Arm Description
Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position
Arm Title
LP in a lying position then LP in a seated position
Arm Type
Other
Arm Description
Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position
Intervention Type
Other
Intervention Name(s)
LP in a seated position then LP in a lying position
Intervention Type
Other
Intervention Name(s)
LP in a lying position then LP in a seated position
Primary Outcome Measure Information:
Title
Pain sensitivity during the lumbar puncture procedure.
Description
It will be evaluated throw specific pain assessment scales according to patient age
Time Frame
duration of the procedure
Secondary Outcome Measure Information:
Title
Anxiety during the lumbar puncture procedure on a scale of one to ten
Time Frame
duration of the procedure
Title
Time of the lumbar puncture procedure
Time Frame
duration of the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Child Positioning on Pain During a Lumbar Puncture
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