The Use of Warmed Saline in Vaso-occlusive Episodes

NCTId: NCT02316366

Official Title

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

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

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 4 Years 21 Years False

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.

Interventions & Outcomes

Study Interventions & Types

Device Intervention(s)

Astoflo Plus fluid warmer - A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Study Outcomes

Primary Outcome(s)

Timeframe: 4 hours
Measure: Rate of Hospital Admission
Description: 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.
Safety Issue? No

Secondary Outcome(s)

Measure: Amount of narcotic administered
Timeframe: 4 hours
Description: The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
Safety Issue? No

Measure: Global comfort
Timeframe: 4 hours
Description: Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay
Safety Issue? No

Measure: Pain Score
Timeframe: 4 hours
Description: During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided.
Safety Issue? No

Measure: Time to disposition
Timeframe: 4 hours
Description: The amount of time spent in the ED was recorded for each patient
Safety Issue? No

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Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Sickle Cell Disease
  2. Sickle Cell Crisis

Other Related Condition Keywords

  1. Anemia, Sickle Cell

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