The Painful Real-life Experience of the Child of Less Than Three Years During the Removal of the Collecting Bags in the Pediatric Urgency: What Strategy of Coverage?
LINIPOCHE
1 other identifier
interventional
136
1 country
1
Brief Summary
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags. Work teams have set as their main goal to compare the different levels of acute pain involved for children under 3 during the removing of the collecting bag, depending on the use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main endpoint, the difference between the results assigned to the acute pain by a pain evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 30, 2025
June 1, 2012
11 months
August 3, 2012
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The level of pain measured by the FLACC scale
5 minutes
Secondary Outcomes (1)
Comparison at the girls and the boys of the score of the FLACC scale
5 minutes
Study Arms (2)
Oiled-limestone liniment
EXPERIMENTALthe removal of the collecting bag is made with the Oiled-limestone liniment.
without Oiled-limestone liniment
NO INTERVENTIONthe removal of the collecting bag is made without any special precautions
Interventions
Eligibility Criteria
You may qualify if:
- The children of zero in 36 months
- Children whose legal representatives accept the participation in the study
- the children must be affiliated or benefit from a health insurance scheme
You may not qualify if:
- Child of more than three years old
- Premature Child
- History of collection bag
- Irritated Siege
- Diarrhea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Limoges university hospital center
Limoges, 87 042, France
Related Publications (1)
Lamy C, Loizeau V, Couquet C, Sturtzer C, Fluteau C, Dugas M, Labrunie A, Marin B, Desfougeres JL, Bahans C, Guigonis V, Beloni P. Pain experienced by infants and toddlers at urine collection bag removal: A randomized, controlled, clinical trial. Int J Nurs Stud. 2019 Jul;95:1-6. doi: 10.1016/j.ijnurstu.2019.03.014. Epub 2019 Mar 23.
PMID: 30981953RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Charles LAMY
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 7, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2013
Study Completion
December 1, 2013
Last Updated
July 30, 2025
Record last verified: 2012-06