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

Azienda Sanitaria dell'Alto Adige

Status and phase: Completed; Phase 4

Conditions: Acute Pain Due to Trauma

Treatments: Drug: Placebo sublingual; Drug: Fentanyl sublingual; Drug: Placebo ev; Drug: Fentanyl ev

Study type: Interventional

Funder types: Other

Identifiers

NCT03080350

SABES Pain 2

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

Fentanyl sublingual + Placebo ev

Experimental group

Description:

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

Treatment:

Drug: Placebo ev

Drug: Fentanyl sublingual

Fentanyl ev + Placebo sublingual

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl ev

Drug: Placebo sublingual