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

This study has been completed.
Sponsor:
Collaborator:
Hopital Debrousse
Information provided by:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00775112
First received: October 16, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Spinal Puncture
Device: pillow

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • technical quality of the LP, classified as success or failure. [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 124
Study Start Date: July 2004
Estimated Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
with pillow
Device: pillow
use of pillow for lumbar punctures
No Intervention: 2
without pillow

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 2 to 18 years undergoing an LP

Exclusion Criteria:

  • Children who had already participated or used the LP pillow
  • medical condition (orthopaedic anomaly) contraindicating the use of the LP pillow
  • Parents refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775112

Locations
France
centre Leon Berard
Lyon, France, 69008
Hopital Debrousse
Lyon, France, 69005
Sponsors and Collaborators
Centre Leon Berard
Hopital Debrousse
  More Information

No publications provided by Centre Leon Berard

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Perrine MAREC-BERARD, Centre Leon Berard
ClinicalTrials.gov Identifier: NCT00775112     History of Changes
Other Study ID Numbers: Lumbar puncture pillow
Study First Received: October 16, 2008
Last Updated: October 16, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
supportive care
lumbar puncture
childhood disease
pediatric hemato-oncology

ClinicalTrials.gov processed this record on October 16, 2014