N/A
N=80
The Use of Warmed Saline in Vaso-occlusive Episodes
Sickle Cell Disease · Sickle Cell Crisis
Bottom Line
View on ClinicalTrials.gov: NCT02316366 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Rate of Hospital Admission — 63; 55 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Astoflo Plus fluid warmer (Device)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Hospital Admission |
63; 55 | — |
| SECONDARY Difference in Pain Score |
-2.6; -2.9 | — |
| SECONDARY Time to Disposition |
158; 155 | — |
| SECONDARY Amount of Narcotic Administered |
0.31; 0.3 | — |
| SECONDARY Global Comfort |
4; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02316366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.