Furosemide Use to Fill the Bladder of Pediatric Females Awaiting Pelvic Ultrasound

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether or not furosemide causes the bladder to fill faster than IV fluids alone so that a pelvic ultrasound exam can be performed.

Detailed Description
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Trans-abdominal pelvic ultrasound is the standard imaging modality for diagnosis of ovarian torsion in the pediatric population, however this requires that the patient have a full bladder at the time of imaging. This study will investigate whether low dose furosemide in addition to IV fluid boluses may provide a fast, effective, and non-invasive means to fill the bladder of pediatric females awaiting pelvic US. The target population are females age 8 to 18 years seen in the emergency room at Connecticut Children's Medical Center who are undergoing a trans-abdominal pelvic ultrasound to assess for ovarian torsion. Enrolled patients will be randomized to the control (IVF bolus only) group vs. the intervention (IVF bolus + furosemide) group and will undergo point-of-care US (POCUS) and bladder scanner evaluation of the bladder every 30 minutes until the bladder is determined to be full.

Official Title
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Utilization of Furosemide to Expedite Bladder Filling in Pediatric Females With Suspected Ovarian Torsion Awaiting Pelvic Ultrasound

Conditions
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Ovarian Torsion

Intervention / Treatment
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* Drug: Furosemide
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females age 8-18yrs seen in the ED at CCMC who are undergoing a trans-abdominal pelvic ultrasound to assess for ovarian torsion Ability of patient (if 18yrs) or parent/legal guardian to sign a written informed consent Exclusion Criteria: History of renal, genitourinary, or pelvic anomalies a. Eg: Chronic kidney disease, anuria, vesicoureteral reflux, ureteral obstruction, urologic reconstructive surgery, suprapubic or pelvic surgery, indwelling urethral catheter, oophorectomy, bicornate uterus Patients with multiple chronic illnesses or systemic neurologic abnormality a. Eg: Bronchopulmonary dysplasia, tracheostomy, gastrostomy tube dependence, cerebral palsy, severe developmental delay, mitochondrial disorder, congenital heart disease, cardiomyopathy, chronic kidney disease, diabetes Patients with known pregnancy Patients deemed to be critically ill a. Mental status changes, signs of end organ damage, hypotension Contraindication to giving Furosemide a. Allergy to sulfonamide medications, severe dehydration, hypotension, underlying electrolyte abnormality, underlying renal disease History of previous diuretic use within the past year Patients who self-report their bladder as being full at the time of enrollment

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide<br>Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and a 0.1mg/kg (max 5mg) furosemide dose | Drug: Furosemide<br>* 0.1mg/kg (max 5mg) of IV furosemide<br>* Other names: Lasix;|
| Placebo Comparator: IV fluids<br>Participants will receive a 20mL/kg (max 1000mL) IV fluid bolus and an IV fluid flush | Drug: Normal saline<br>* 20mL/kg (max 1000mL) normal saline bolus plus a normal saline flush<br>* Other names: IV fluids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time from initiation of the intervention to the time that the bladder reaches large, ovoid shape on POCUS exam | Initiation of the intervention is defined as administration of furosemide vs. normal saline flush. | Through study completion, about 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between bladder volume as calculated on POCUS exam of a large, ovoid bladder and bladder volume as reported by bladder scanner | Measurements will be completed every 30 minutes through study completion | Through study completion, about 3 hours | 
| Number and nature of all reports of adverse events related to furosemide administration | Adverse events include signs of severe dehydration, allergic reaction, and electrolyte abnormality | From time of intervention until final disposition, about 6 hours | 
| The time from initiation of the intervention to the time of completion of successful radiology-performed pelvic US |  | About 3 hours | 
| The time from initiation of intervention to the time of admission or discharge order placement |  | From time of intervention until final disposition, about 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Point-of-care Ultrasound, Bladder volume