Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology
We have developed a positioning cushion for LP which allows the child to be relaxed in an adequate position, and to maintain this position throughout LP. This study was aimed at evaluating the benefit of the device on the technical quality of LPs, on pain, anxiety, post LP syndrome, and on the satisfaction of children, their parents and caregivers.
The study was a two-centre, open, randomized trial, with two parallel groups. Children aged 2 to 18 years undergoing a LP were eligible, if not included in the study before. Those who had used the cushion before, with a medical reason preventing the use of the cushion, those refusing or whose parents refused could not be included. Randomization was stratified by centre.
Four cushion sizes were available for the age ranges: 2-6 years, 6-10 years, 10-15 and 15-18 years. The primary outcome was the rate of success, defined as a LP reaching its objective at the first attempt, without hemorrhage (visible hemorrhage or RBC > 50/mm3 in the CSF sample). Secondary outcomes included: the child's pain using a visual analogic scale (VAS), parents and caregiver perception of the child's pain (VAS); the children, parents, caregiver and physician performing the LP satisfaction; children cooperation using the "Le Baron Scale", and the occurrence of a post LP syndrome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology|
- technical quality of the LP, classified as success or failure. [ Time Frame: immediate ] [ Designated as safety issue: No ]
- child's pain [ Time Frame: immediate ] [ Designated as safety issue: No ]
- satisfaction of the children, parents, caregivers and physician performing the LP assessed using verbal scoring; [ Time Frame: immediate ] [ Designated as safety issue: No ]
- number of attending persons [ Time Frame: immediate ] [ Designated as safety issue: No ]
- symptoms and duration of post-LP syndrome assessed 48 hours after LP [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Estimated Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
use of pillow for lumbar punctures
No Intervention: 2
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00775112
|Lyon, France, 69005|
|centre Leon Berard|
|Lyon, France, 69008|