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OpenTrials
Completed

NCT Number: NCT03263845

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

Observational study.

Completed

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Key information

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 35200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation of pain

    Time frame: Day 0

    Score of the visual analog scale rated by the caregiver during the first performed gesture.

Secondary outcomes

  1. Evaluation of pain

    Time frame: Day 0

    Score of the visual analog scale rated by the parent during the first performed gesture.

  2. Evaluation of pain

    Time frame: Day 0

    Score of the visual analog scale rated by the parent and the caregiver for the following gestures

  3. The experience of the gesture by the parent and the caregiver

    Time frame: Day 0

    Evaluation by a questionnaire by choosing from the following proposals:

    Very well spent, well spent, badly spent or very badly spent

  4. Time needed to collect urine

    Time frame: Day 0

    Duration between the first gesture and the final urine collection

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: SONDAPU

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2017
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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