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

Urinary Tract Infections in Children Clinical Trial

— SONDAPU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263845
• Other study ID #: 35RC16_3036_SONDAPU
• Status: Completed
• Phase: N/A
• First received: August 24, 2017
• Last updated: August 24, 2017
• Start date: July 5, 2016
• Est. completion date: January 13, 2017

Study information

• Verified date: August 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 13, 2017
• Est. primary completion date: January 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Urinary Tract Infections
• Urinary Tract Infections in Children

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain	Score of the visual analog scale rated by the caregiver during the first performed gesture.	Day 0
Secondary	Evaluation of pain	Score of the visual analog scale rated by the parent during the first performed gesture.	Day 0
Secondary	Evaluation of pain	Score of the visual analog scale rated by the parent and the caregiver for the following gestures	Day 0
Secondary	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
Secondary	Time needed to collect urine	Duration between the first gesture and the final urine collection	Day 0