N/A
N=45
BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment
Point-of-Care Bladder Ultrasound · Urethral Catheter
Bottom Line
View on ClinicalTrials.gov: NCT03860311 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Time to Successful Completion of Pelvic Ultrasound — 103.95; 92.82 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bladder Ultrasound (Device); Standard of Care (Other)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Successful Completion of Pelvic Ultrasound |
103.95; 92.82 | — |
| SECONDARY Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS) |
3.60; 6.23 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03860311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.