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

NCT03080350 | Completed Phase 4

• 1 other identifier: SABES Pain 2
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Pain Due to Trauma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain - Relief

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

  1 hour

Secondary Outcomes (4)

• Practicability / handling of the two dosage forms of fentanyl in emergencies

  1 hour

• Patient comfort

  1 hour

• Adverse drug effects

  1 hour

• SpO2 (%)

  1 hour

Study Arms (2)

Fentanyl sublingual + Placebo ev

EXPERIMENTAL

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

Drug: Fentanyl sublingual; Drug: Placebo ev

Fentanyl ev + Placebo sublingual

ACTIVE COMPARATOR

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

Drug: Fentanyl ev; Drug: Placebo sublingual

Interventions

Fentanyl sublingual DRUG

Fentanyl sublingual

Also known as: Abstral

Fentanyl sublingual + Placebo ev

Fentanyl ev DRUG

Fentanyl ev

Fentanyl ev + Placebo sublingual

Placebo sublingual DRUG

Placebo sublingual

Fentanyl ev + Placebo sublingual

Placebo ev DRUG

Placebo - NaCL 0,9% ev

Fentanyl sublingual + Placebo ev

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma on the limbs with a pain score of 4 or more on the slope
• ASA I - II

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria dell'Alto Adige: lead
• Institute of Mountain Emergency Medicine: collaborator

Study Sites (1)

Skiresort - Kronplatz

Bruneck, 39031, Italy

Location

MeSH Terms

Conditions

Agnosia

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rosmarie Oberhammer, MD

  Südtiroler Sanitätsbetrieb - Bruneck Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: March 15, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)