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

Phase 4

Completed

• Conditions: Acute Pain Due to Trauma
• Interventions: Drug: Fentanyl sublingual; Drug: Fentanyl ev; Drug: Placebo ev; Drug: Placebo sublingual

• Registration Number: NCT03080350
• Lead Sponsor: Azienda Sanitaria dell'Alto Adige

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-12-04
• Study Start: 2017-01
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl sublingual + Placebo ev	Fentanyl sublingual	Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev
Fentanyl sublingual + Placebo ev	Placebo ev	Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev
Fentanyl ev + Placebo sublingual	Fentanyl ev	Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual
Fentanyl ev + Placebo sublingual	Placebo sublingual	Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual

Primary Outcome Measures

Name	Time	Method
Pain - Relief	1 hour	Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)

Secondary Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

Skiresort - Kronplatz; 🇮🇹 Bruneck, Italy