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

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ClinicalTrials.gov Identifier: NCT02834156
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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.


Condition or disease Intervention/treatment Phase
Hematological Malignancies Other: LP in a seated position then LP in a lying position Other: LP in a lying position then LP in a seated position Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : August 23, 2017
Actual Study Completion Date : August 23, 2017

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834156


Locations
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France
CHU de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02834156     History of Changes
Other Study ID Numbers: 15-PP-05
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms