drugset / Trial / NCT01482091
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.
Timeline
- Start
- 2011-12
- Primary completion
- 2015-02
- Completion
- —
Outcome
Met primary endpoint
registry MEDIAN Intranasal Saline: 1 (0 to 2) units on a scale MEDIAN Intranasal Fentnayl: 2 (0.5 to 4) units on a scale NCT01482091 ↗
registry analysis (superiority or other test); Intranasal Saline vs Intranasal Fentnayl; p = 0.048; Wilcoxon (Mann-Whitney) NCT01482091 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | 2 ug/kg | Intranasal |