drugset / Trial / NCT03933397
Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
Phase 3
Terminated
328 enrolled
Duke University
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.
Timeline
- Start
- 2019-08-13
- Primary completion
- 2022-05-13
- Completion
- 2022-05-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydromorphone | Other / unclassified | 1 mg | — |
| Subject | Hydromorphone | Other / unclassified | 1.5 mg | — |
| Subject | Hydromorphone | Other / unclassified | 2 mg | — |
| Subject | Morphine | Other / unclassified | 4 mg | — |
| Subject | Morphine | Other / unclassified | 6 mg | — |
| Subject | Morphine | Other / unclassified | 8 mg | — |
| Subject | Morphine | Other / unclassified | 10 mg | — |