Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Completed · Phase 4
Conditions studied: Sickle Cell Disease
In brief
The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
Key facts
- Study ID
- NCT02222246
- Run by
- Duke University
- People needed
- 106
- Starts
- 2015-03-15
- Expected to finish
- 2016-06-30
- Last updated by the study team
- 2017-08-04
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult SCD patients with genotypes SS, SC, SB+, or SB-
You may not qualify if…
- Patients with sickle cell trait
- Allergic to both morphine sulfate and hydromorphone,
- Patients who have an explicit care plan that states they cannot be admitted to the hospital for pain control,
- Non-English speaking,
- Patients admitted for a medical complication,
- Record of >24 ED visits in the prior 12 months,
- Children
Where it is running
- Mount Sinai Hospital — New York, New York, United States
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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