Impact of Child Positioning on Pain During a Lumbar Puncture
PHIPA-PEPL
Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2017
CompletedMarch 12, 2018
March 1, 2018
2.2 years
July 8, 2016
March 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
LP in a seated position then LP in a lying position
OTHERPatients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position
LP in a lying position then LP in a seated position
OTHERPatients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, 06000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2016
First Posted
July 15, 2016
Study Start
June 30, 2015
Primary Completion
August 23, 2017
Study Completion
August 23, 2017
Last Updated
March 12, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share