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

NCT03080350 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-03-04

No results posted yet for this study

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

Conditions

  • Acute Pain Due to Trauma

Interventions

DRUG

Fentanyl sublingual

Fentanyl sublingual

DRUG

Fentanyl ev

Fentanyl ev

DRUG

Placebo sublingual

Placebo sublingual

DRUG

Placebo ev

Placebo - NaCL 0,9% ev

Sponsors & Collaborators

  • Institute of Mountain Emergency Medicine

    collaborator OTHER

  • Azienda Sanitaria dell'Alto Adige

    lead OTHER

Principal Investigators

  • Rosmarie Oberhammer, MD · Südtiroler Sanitätsbetrieb - Bruneck Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03080350 on ClinicalTrials.gov