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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Acute Pain Due to Trauma

Intervention / Treatment
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* Drug: Fentanyl sublingual
* Drug: Fentanyl ev
* Drug: Placebo sublingual
* Drug: Placebo ev


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl sublingual + Placebo ev<br>Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev | Drug: Fentanyl sublingual<br>* Fentanyl sublingual<br>* Other names: Abstral;Drug: Placebo ev<br>* Placebo - NaCL 0,9% ev<br>|
| Active Comparator: Fentanyl ev + Placebo sublingual<br>Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual | Drug: Fentanyl ev<br>* Fentanyl ev<br>Drug: Placebo sublingual<br>* Placebo sublingual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 hour | 
| Adverse drug effects | such as pruritus, nausea, dizziness | 1 hour | 
| SpO2 (%) | SpO2 < 92% | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fentanyl, Transmucosal administration, Endovenous administration, Pain therapy, Mountain emergency medicine