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

Acute Pain Due to Trauma Clinical Trial

Official title:
Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - a Double-blind Randomized Prospective Study

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03080350
Study type Interventional
Source Azienda Sanitaria dell'Alto Adige
Contact
Status Completed
Phase Phase 4
Start date January 2017
Completion date March 2018
View Details
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