NCT03080324

Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room

Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the ER - a Double-blind Randomized Prospective Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Azienda Sanitaria dell'Alto Adige · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the non-inferiority of the efficacy of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.

Detailed description

Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough pain relief in oncologic patients. The immediate (10 minutes) effect and the ease of administration of sublingual fentanyl could be a possibility for a fast pain relief in remote areas such as mountain rescue missions. Patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev. Safety issues like control of vital signs will be warranted

Conditions

• Acute Pain Due to Trauma

Interventions

Type	Name	Description
DRUG	Fentanyl sublingual	Fentanyl sublingual
DRUG	Fentanyl ev	Fentanyl ev
DRUG	Placebo sublingual	Placebo sublingual
DRUG	Placebo ev	Saline

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-05-15
• Completion: 2017-05-15
• First posted: 2017-03-15
• Last updated: 2020-03-04

Locations

1 site across 1 country: Italy