A Phase 4 interventional study of Fentanyl sublingual and Fentanyl ev in Acute Pain Due to Trauma, sponsored by Azienda Sanitaria dell'Alto Adige. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Azienda Sanitaria dell'Alto Adige · Phase 4, Interventional, and Treatment
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 108 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Azienda Sanitaria dell'Alto Adige is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev
Drug: Fentanyl sublingual · Drug: Placebo ev
Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual
Drug: Fentanyl ev · Drug: Placebo sublingual
Fentanyl sublingual
Also known as: Abstral
Fentanyl ev
Placebo sublingual
Placebo - NaCL 0,9% ev
Pain - Relief
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)
Time frame: 1 hour
Practicability / handling of the two dosage forms of fentanyl in emergencies
Practicability / handling
Time frame: 1 hour
Patient comfort
5 items Labert Scale
Time frame: 1 hour
Adverse drug effects
such as pruritus, nausea, dizziness
Time frame: 1 hour
SpO2 (%)
SpO2 \< 92%
Time frame: 1 hour
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Azienda Sanitaria dell'Alto Adige