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

NCT00775112 | Completed

• 1 other identifier: Lumbar puncture pillow
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

supportive care; lumbar puncture; childhood disease; pediatric hemato-oncology

Outcome Measures

Primary Outcomes (1)

• technical quality of the LP, classified as success or failure.

  immediate

Secondary Outcomes (4)

• child's pain

  immediate

• satisfaction of the children, parents, caregivers and physician performing the LP assessed using verbal scoring;

  immediate

• number of attending persons

  immediate

• symptoms and duration of post-LP syndrome assessed 48 hours after LP

  48 hours

Study Arms (2)

1

EXPERIMENTAL

with pillow

Device: pillow

2

NO INTERVENTION

without pillow

Interventions

pillow DEVICE

use of pillow for lumbar punctures

1

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 2 to 18 years undergoing an LP

You may not qualify if:

• Children who had already participated or used the LP pillow
• medical condition (orthopaedic anomaly) contraindicating the use of the LP pillow
• Parents refusal

Sponsors & Collaborators

• Centre Leon Berard: lead
• Hopital Debrousse: collaborator

Study Sites (2)

Hopital Debrousse

Lyon, 69005, France

Location

centre Leon Berard

Lyon, 69008, France

Location

Related Publications (1)

• Marec-Berard P, Bissery A, Kebaili K, Schell M, Aubert F, Gaillard S, Rabilloud M, Kassai B, Cornu C. A positioning pillow to improve lumbar puncture success rate in paediatric haematology-oncology patients: a randomized controlled trial. BMC Cancer. 2009 Jan 15;9:21. doi: 10.1186/1471-2407-9-21.

  PMID: 19146666 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: July 1, 2004
• Primary Completion: September 1, 2006
• Last Updated: October 17, 2008

Record last verified: 2008-10

Locations

FR (2)