Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room

NCT03080324 | Completed Phase 4

• 1 other identifier: SABES 1
• 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 of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.

Conditions

Acute Pain Due to Trauma

Keywords

Fentanyl; Transmucosal administration; Endovenous administration; Pain therapy

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

Also known as: Fentanest

Fentanyl ev + Placebo sublingual

Placebo sublingual DRUG

Placebo sublingual

Also known as: Placebo

Fentanyl ev + Placebo sublingual

Placebo ev DRUG

Saline

Also known as: Saline

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
• ASA I - II

You may not qualify if:

• children \< 18 years
• cognitive impairment: brain injury, intoxication, analgesia
• weight under 50 kg and more then 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

Study Sites (1)

Emergency Room of Bruneck Regional Hospital

Bruneck, 39031, Italy

Location

MeSH Terms

Conditions

Agnosia

Interventions

Fentanyl; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Elisabeth Gruber, MG MSc

  Südtiroeler Sanitätsbetrieb

  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: December 1, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)