drugset / Trial / NCT01482091

Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

NCT01482091 ↗

Phase 4 Completed 124 enrolled Montefiore Medical Center
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

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 2 ug/kg Intranasal

Indications