NCT03080350

Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope

Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - 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 for prehospital analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for patients with limb trauma on the slope

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 cancer pain relief in oncologic patients. The immediate (less than 10 minutes) effect and the ease of administration of sublingual fentanyl is a feasible drug administration for immediate analgesia in remote areas such as mountain rescue missions eg. the slope. 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	Placebo - NaCL 0,9% ev

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2017-03-15
• Last updated: 2020-03-04

Locations

1 site across 1 country: Italy