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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl sublingual | Drug | Fentanyl sublingual |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain - Relief | Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Practicability / handling of the two dosage forms of fentanyl in emergencies | Practicability / handling | 1 hour |
| Patient comfort | 5 items Labert Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Gruber, MG MSc | Südtiroeler Sanitätsbetrieb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Room of Bruneck Regional Hospital | Bruneck | 39031 | Italy |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
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| Fentanyl ev | Drug | Fentanyl ev |
|
|
| Placebo sublingual | Drug | Placebo sublingual |
|
|
| Placebo ev | Drug | Saline |
|
|
| 1 hour |
| Adverse drug effects | such as pruritus, nausea, dizziness | 1 hour |
| SpO2 (%) | SpO2 < 92% | 1 hour |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |