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Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology

NCT00775112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2008-10-17

No results posted yet for this study

Summary

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.

Conditions

  • Spinal Puncture

Interventions

DEVICE

pillow

use of pillow for lumbar punctures

Sponsors & Collaborators

  • Hopital Debrousse

    collaborator UNKNOWN

  • Centre Leon Berard

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2006-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00775112 on ClinicalTrials.gov