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Completed

NCT Number: NCT03860311

BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment

In this study patients presenting to the pediatric ER with abdominal or pelvic complaints will be randomized to urethral bladder catheter or bladder ultrasound to compare time to completion of successful pelvic ultrasound, as determined by full visualization of uterus and ovaries.

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Key information

About this study

In this study, we will enroll female pediatric emergency department (ED) patients presenting with a diagnosis of abdominal pain who may have a transabdominal pelvic ultrasound ordered by their treating physician (or nurse practitioner). In order to maximize the visualization of organs deep within the pelvis such as the ovaries and uterus, the patient's bladder must be full. The current practice at our institution, as well as numerous others, is to have a bladder catheter placed immediately when a transabdominal pelvic ultrasound is ordered, and then to fill the bladder in a retrograde manner in order to provide enhanced visualization of the pelvic structures. The process of inserting a bladder catheter into a pediatric patient is an invasive procedure which can be traumatic and painful to the patient. Additionally, if the patient's bladder is already full, this procedure may be unnecessary.

In this study, a point-of-care bladder ultrasound will be performed, upon enrollment of a patient by a study bedside sonographer (our pediatric emergency department nurse practitioners), to assess degree of bladder fullness. This measurement will then be repeated serially while the patient is receiving hydration and the ultrasound will be performed when the bladder is full. We hypothesize that this work flow will result in an equivalent time to transabdominal pelvic ultrasound completion and will reduce the number of potentially traumatic and painful, invasive urethral bladder catheterizations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 8yr-18yrs
  • Female
  • Likely to have order placed for transabdominal pelvic ultrasound/ovarian ultrasound
  • No history of pelvic or bladder reconstructive surgery

Exclusion criteria

  • Pregnancy (known)
  • Critically ill patients
  • Patients with known renal or genitourinary structural abnormalities or prior pelvic/genitourinary surgery
  • Chronic renal disease
  • Patients presenting outside the defined treatment windows

Treatment and study plan

Bladder ultrasound

Device

Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is "full," or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound.

Standard of care

Other

Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.

Primary outcomes

  1. Time to Successful Completion of Pelvic Ultrasound

    Time frame: Baseline to 180 minutes

    Time zero (order placed) to time completed (time pelvic ultrasound images are completed)

Secondary outcomes

  1. Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)

    Time frame: When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes

    All participating patients, in either arm, will be given a single-question on pain related to their receipt of bladder ultrasound(s) or bladder catheter. The VNRS uses a 0-10 scale accompanied by faces that pictorially represent the level of pain, 0 being no pain, and 10 being the worst pain. Measurements will start at time when bladder ultrasound(s) are performed OR time when bladder catheter is inserted) to time of completion (time pelvic ultrasound is completed).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: BULLET

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2019
Registry last updated
Jun 1, 2022

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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