A positioning pillow to improve lumbar puncture success rate in paediatric haematology-oncology patients: a randomized controlled trial
1 Service d'Oncologie Pédiatrique, Institut d'Hémato-Oncologie Pédiatrique, Centre Léon Bérard, Lyon, France
2 Hospices Civils de Lyon, Service de Biostatistique; CNRS, UMR 5558, Villeurbanne; Université Claude Bernard, Laboratoire Biostatistique Santé, Lyon, F-69003, France
3 Hospices Civils de Lyon, Service d'hématologie pédiatrique; Lyon, F-69000 France
4 INSERM, CIC201, EPICIME, Lyon, F-69000 France; CHU Lyon, Service de Pharmacologie Clinique, Lyon, F-69000 France; Univ Lyon, UMR 5558, Lyon, F-69000 France
BMC Cancer 2009, 9:21 doi:10.1186/1471-2407-9-21Published: 15 January 2009
Lumbar punctures (LPs) are common in children with cancer. Although pain management during the lumbar puncture has been well standardized, dealing with stress and anxiety is not well addressed yet. Our objective was to evaluate the potential improvement of the LP success rate using a positioning pillow, to ensure maximum lumbar flexion, and allow paravertebral muscles to relax, in children who are awake, with either conscious sedation or no sedation.
Children aged 2–18 years undergoing LP were randomly assigned to a positioning pillow or no intervention. The primary outcome was the rate of success, i.e. achieving the LP (sampling or injection) at the first attempt, without bleeding (RBC < 50/mm3). The secondary outcomes included: the child's pain, assessed by a self-administered visual analogical scales (VAS) for children over 6 years of age; the parents' and caregivers' perception of the child's pain; the satisfaction of the children, the parents, the caregivers and the physician. The child's cooperation and the occurrence of post-LP syndrome were also evaluated.
124 children (62 in each group) were included. The LP pillow tended to increase the success rate of LPs (67% vs. 57%, p = 0.23), and decreased the post-LP syndromes (15% vs. 24%, p = 0.17) but the differences were not statistically significant. In children over 6-year of age (n = 72), the rate of success was significantly higher in the pillow group (58.5% vs. 41.5%, p = 0.031), with a tendency to feel less pain (median VAS 25 vs. 15 mm, p = 0.39) and being more satisfied (84.4% vs. 75.0%, p = 0.34).
Overall results do not demonstrate a benefit in using this pillow for lumbar punctures. This study results also suggest a benefit in the sub group of children over 6-year of age; this result needs confirmation.
The trial was registered with Clinical Trials.gov (number NCT00775112).