drugset / Trial / NCT02137525
Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain. After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician. Adverse events will be collected for five days after initial enrollment.
Timeline
- Start
- —
- Primary completion
- 2017-06-29
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | 100 ug | Other |
| Subject | Fentanyl | Other / unclassified | 200 ug | Other |
| Subject | Fentanyl | Other / unclassified | 400 ug | Other |
| Comparator | Morphine | Other / unclassified | 6 mg | Intravenous |
Indications
No indication recorded.