Impact of Child Positioning on Pain During a Lumbar Puncture (PHIPA-PEPL)

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

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.

Study Overview

• Status: Completed
• Conditions: Hematological Malignancies
• Intervention / Treatment: Other: LP in a seated position then LP in a lying position; Other: LP in a lying position then LP in a seated position

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LP in a seated position then LP in a lying position; Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position	Other: LP in a seated position then LP in a lying position
Other: LP in a lying position then LP in a seated position; Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position	Other: LP in a lying position then LP in a seated position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain sensitivity during the lumbar puncture procedure.	It will be evaluated throw specific pain assessment scales according to patient age	duration of the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Anxiety during the lumbar puncture procedure on a scale of one to ten	duration of the procedure
Time of the lumbar puncture procedure	duration of the procedure

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2015
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): August 23, 2017

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 15-PP-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO