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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03080350

Enrollment

108

Registered

2017-03-15

Start date

2017-01-31

Completion date

2018-03-31

Last updated

2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain Due to Trauma

Keywords

Fentanyl, Transmucosal administration, Endovenous administration, Pain therapy, Mountain emergency medicine

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.

Interventions

DRUGFentanyl sublingual

Fentanyl sublingual

DRUGFentanyl ev

Fentanyl ev

DRUGPlacebo sublingual

Placebo sublingual

DRUGPlacebo ev

Placebo - NaCL 0,9% ev

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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%

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026