Impact of Child Positioning on Pain During a Lumbar Puncture

Hematological Malignancies Clinical Trial

— PHIPA-PEPL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834156
• Other study ID #: 15-PP-05
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: March 8, 2018
• Start date: June 30, 2015
• Est. completion date: August 23, 2017

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 23, 2017
• Est. primary completion date: August 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematological Malignancies

Intervention

Other:
• LP in a seated position then LP in a lying position

• LP in a lying position then LP in a seated position

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anxiety during the lumbar puncture procedure on a scale of one to ten		duration of the procedure
Secondary	Time of the lumbar puncture procedure		duration of the procedure