N/A
Completed N=80
The Use of Warmed Saline in Vaso-occlusive Episodes
Sickle Cell Disease · Sickle Cell Crisis
Source: ClinicalTrials.gov NCT02316366 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Rate of Hospital Admission — 63; 55 percentage of participants
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.
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 | — |
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. Informational only — not medical advice.