Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness (SONDAPU)

Round-trip Survey or Urine Bag: Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness (SONDAPU)

Observational study.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections in Children

Detailed Description

Febrile urinary infections account for 5% of unexplained causes of fever in children up to 2 years of age. Urinary samples are therefore very common in pediatric emergencies. In children who have not acquired cleanliness, the most used method of collection is the placement of a sterile urine bag on the perineum. It allows a noninvasive urinary collection. However from a bacteriological point of view this method is debatable because the rate of contamination of the collections is important. This mode of collection is of interest only to exclude a urinary infection, by the realization of a urinary strip.

Pocket-collected urine is not reliable for bacteriological analysis in culture. For example, if the urine strip is positive, the American Academy of Pediatrics recommends urine sampling by urine sampling (or other invasive methods) for culture.

The urine bag should be changed every 30 minutes to avoid the risk of contamination. The technique is wait-and-see, the installation of several pockets is often necessary before obtaining urine.

A study carried out in 2014 shows that in 39.4% of the cases the withdrawal of the urinary pouch was as much more painful than the urinary sounding, in the same patient. To our knowledge there is no other study dealing with the difference in pain engendered by these two methods.

Since the urinary catheterization is faster, bacteriologically justified and necessary if the pocket collection is positive, it seems legitimate to ask ourselves if we should not aim at a generalization of the urinary catheterization, as first intention, Having not acquired cleanliness, requiring a withdrawal of urine for suspicion of urinary infection.

Many centers continue to use urinary pocket collection mainly, as the survey technique seems too invasive and painful.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35200
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.

Description

Inclusion Criteria:

Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pain	Score of the visual analog scale rated by the caregiver during the first performed gesture.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pain	Score of the visual analog scale rated by the parent during the first performed gesture.	Day 0
Evaluation of pain	Score of the visual analog scale rated by the parent and the caregiver for the following gestures	Day 0
The experience of the gesture by the parent and the caregiver	Evaluation by a questionnaire by choosing from the following proposals: Very well spent, well spent, badly spent or very badly spent	Day 0
Time needed to collect urine	Duration between the first gesture and the final urine collection	Day 0

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Amelie Rickewaert, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2016
• Primary Completion (ACTUAL): January 13, 2017
• Study Completion (ACTUAL): January 13, 2017

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (ACTUAL): August 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Disease Attributes; Emergencies; Urinary Tract Infections
• Other Study ID Numbers: 35RC16_3036_SONDAPU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No