Clinical trial NCT02316366: The Use of Warmed Saline in Vaso-occlusive Episodes
Official title: Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Sickle Cell Crisis
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Hospital Admission
timeFrame: 4 hours
Secondary outcomes:
measure: Difference in Pain Score
timeFrame: 4 hours
measure: Time to Disposition
timeFrame: 4 hours
measure: Amount of Narcotic Administered
timeFrame: 4 hours
measure: Global Comfort
timeFrame: 4 hours
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Childrens Hospital
name: Renee Quarrie, MD
role: PRINCIPAL_INVESTIGATOR
References:
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