Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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 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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Fentanyl sublingual + Placebo ev Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev |
Drug: Fentanyl sublingual
Fentanyl sublingual
Other Names:
Drug: Placebo ev
Saline
Other Names:
|
Active Comparator: Fentanyl ev + Placebo sublingual Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual |
Drug: Fentanyl ev
Fentanyl ev
Other Names:
Drug: Placebo sublingual
Placebo sublingual
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain - Relief [1 hour]
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)
Secondary Outcome Measures
- Practicability / handling of the two dosage forms of fentanyl in emergencies [1 hour]
Practicability / handling
- Patient comfort [1 hour]
5 items Labert Scale
- Adverse drug effects [1 hour]
such as pruritus, nausea, dizziness
- SpO2 (%) [1 hour]
SpO2 < 92%
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Trauma on the limbs with a pain score of 4 or more
-
ASA I - II
Exclusion Criteria:
-
children < 18 years
-
cognitive impairment: brain injury, intoxication, analgesia
-
weight under 50 kg and more then 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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Emergency Room of Bruneck Regional Hospital | Bruneck | Italy | 39031 |
Sponsors and Collaborators
- Azienda Sanitaria dell'Alto Adige
Investigators
- Principal Investigator: Elisabeth Gruber, MG MSc, Südtiroeler Sanitätsbetrieb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SABES 1