The Use of Warmed Saline in Vaso-occlusive Episodes

Nationwide Children's Hospital

Status

Completed

Conditions

Sickle Cell Crisis

Sickle Cell Disease

Treatments

Device: Astoflo Plus fluid warmer

Study type

Interventional

Funder types

Other

Identifiers

NCT02316366

IRB12-00295

Details and patient eligibility

About

The purpose of this study is to determine if warming the intravenous (IV) fluid given to patients with Sickle Cell Disease who are experiencing painful episodes known as Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV pain medications given, improve pain and improve global comfort.

Full description

Vaso-occlusive crisis (VOC) is a common painful complication of Sickle Cell Disease and is the primary reason that these patients seek medical care in the acute care setting. This complication arises when blood vessels are obstructed by sickled red blood cells resulting in ischemic injury.

The standard management of these painful episodes comprises the administration of opioid analgesics, the infusion of intravenous (IV) fluids at room temperature and rest. These episodes often last five to seven days and many patients require inpatient management for continued administration of intravenous analgesics.

The public health impact of the disease is large as admissions frequently result in school or work absences and can be financially and emotionally taxing.

It is well established that exposure to cold precipitates VOC. For this reason, management of the pain of VOC in some centers includes the use of warming blankets as an adjunct for pain relief. It is conceptually appealing to conjecture that warm fluids might have similar salutary effects on VOC. This conjecture is bolstered by the physiologic effect of temperature on vascular tone. Specifically, it is well established that cold temperatures cause vasoconstriction whereas warm temperatures cause vasodilation. We expect that warmed fluids will similarly induce vasodilation, improving blood flow to vaso-occluded ischemic areas.

Enrollment

80 patients

Sex

All

Ages

4 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Vaso-occlusive Episode defined as a pain rating of 3 or above on the Wong-Baker FACES score in a child with an established diagnosis of sickle cell disease (SS, SC or S β Thalassemia)
4-21 years of age

Exclusion criteria

fever (temperature greater than 38 degrees Celsius)
inability to complete FACES pain scale
evidence of acute chest syndrome clinically or radiographically
deemed by attending physician to be so ill as to need immediate hospital admission.