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OpenTrials
Completed

NCT Number: NCT02834156

Impact of Child Positioning on Pain During a Lumbar Puncture

This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children.

It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

About this study

In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are essential to diseases diagnosis and treatment.

In hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization.

Two positions are possible to carry out lumbar puncture: seated or lying position.

The main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress.

This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is 1 year, 30 patients will be included from 2 to 18 years old.

Each patient will have 2 LP one in seated and one in lying position in a specific order determined by randomization.

All data regarding pain and anxiety will be collected the day of LP. Patients will be re contacted 48 hours and 15 days after LP procedure in order to evaluate complications such post-lumbar puncture syndrome or hematoma. The main analysis will be done on intent-to-treat-analysis basis and will compare pain intensity between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 2 and 18 years old
  • Patients requiring at least 2 therapeutic lumbar punctures
  • Patients able to receive analgesic procedure according to 20005 good practices recommendation
  • Presence of one parent during LP procedure
  • Child able to use assessment scales
  • LP realized with a 20 G needle
  • Platelets > 50000
  • Child with prior clinical examination
  • Affiliated to a health care insurance regimen

Exclusion criteria

  • Seated or lying position impossible
  • Lumbar puncture contraindication
  • Patient or parent opposition to second LP realization in the required position
  • Clotting trouble on LP day not allowing the LP procedure

Treatment and study plan

LP in a seated position then LP in a lying position

Other

LP in a lying position then LP in a seated position

Other

Primary outcomes

  1. Pain sensitivity during the lumbar puncture procedure.

    Time frame: duration of the procedure

    It will be evaluated throw specific pain assessment scales according to patient age

Secondary outcomes

  1. Anxiety during the lumbar puncture procedure on a scale of one to ten

    Time frame: duration of the procedure

  2. Time of the lumbar puncture procedure

    Time frame: duration of the procedure

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children

Acronym: PHIPA-PEPL

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2016
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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