NCT05098366

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Connecticut Children's Medical Center · Academic / Other
• Sex: Female
• Age: 8 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Ovarian Torsion

Interventions

Type	Name	Description
DRUG	Furosemide	0.1mg/kg (max 5mg) of IV furosemide
DRUG	Normal saline	20mL/kg (max 1000mL) normal saline bolus plus a normal saline flush

Timeline

• Start date: 2021-05-29
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-10-28
• Last updated: 2024-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study