The Use of Warmed Saline in Vaso-occlusive Episodes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes

Conditions
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Sickle Cell Disease, Sickle Cell Crisis

Intervention / Treatment
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* Device: Astoflo Plus fluid warmer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm fluid<br>Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer | Device: Astoflo Plus fluid warmer<br>* A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius<br>|
| No Intervention: Room temperature Fluid<br>Patients receive intravenous saline at room temperature (22-24 degrees Celsius) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hospital Admission | After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded. | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pain Score | During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided. The difference between the pain score upon arrival and at discharge was assessed. Minimum value 1, maximum value 10 (most pain) | 4 hours | 
| Time to Disposition | The amount of time spent in the ED was recorded for each patient | 4 hours | 
| Amount of Narcotic Administered | The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient | 4 hours | 
| Global Comfort | Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay. Question 2 of the survey addressed comfort by asking: On a scale of 1 to 5, how do you think the fluid made you feel? (1 is worse and 5 is better). | 4 hours |