Trial | NCT03080350  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fentanyl ...

  • Study Participants

    108
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
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 Started
Jan 31
2017
Primary Completion
Mar 31
2018
Study Completion
Mar 31
2018
Last Update
Mar 04
2020

Drug Fentanyl sublingual

Fentanyl sublingual

  • Other names: Abstral

Drug Fentanyl ev

Fentanyl ev

Drug Placebo sublingual

Placebo sublingual

Drug Placebo ev

Placebo - NaCL 0,9% ev

Fentanyl sublingual + Placebo ev Experimental

Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev

Fentanyl ev + Placebo sublingual Active Comparator

Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual

Criteria 

Inclusion Criteria:

Trauma on the limbs with a pain score of 4 or more on the slope
ASA I - II

Exclusion Criteria:

children (< 18 years)
cognitive impairment: brain injury, intoxication, analgesia
weight under 50 kg and more than 100 kg
other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation;
chronic analgesic use or misuse
allergy
fear of needles
pregnancy
speech difficulties
No Results Posted