Clinical trial NCT03860311: BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment
Official title: BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Point-of-Care Bladder Ultrasound
Urethral Catheter
Keywords: Ovarian Torsion
Point-of-Care
Pelvic pain
Bedside Ultrasound
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 45
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Successful Completion of Pelvic Ultrasound
timeFrame: Baseline to 180 minutes
Secondary outcomes:
measure: Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)
timeFrame: When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kathleen R Richard, MD
role: PRINCIPAL_INVESTIGATOR
References: