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

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

Study Overview

• Status: Completed
• Conditions: Acute Pain Due to Trauma
• Intervention / Treatment: Drug: Fentanyl sublingual; Drug: Placebo ev; Drug: Fentanyl ev; Drug: Placebo sublingual

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bruneck, Italy, 39031
    • Skiresort - Kronplatz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl sublingual + Placebo ev; Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev	Drug: Fentanyl sublingual; Fentanyl sublingual; Other Names: Abstral; Drug: Placebo ev; Placebo - NaCL 0,9% ev
Active Comparator: Fentanyl ev + Placebo sublingual; Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual	Drug: Fentanyl ev; Fentanyl ev; Drug: Placebo sublingual; Placebo sublingual

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Practicability / handling of the two dosage forms of fentanyl in emergencies	Practicability / handling	1 hour
Patient comfort	5 items Labert Scale	1 hour
Adverse drug effects	such as pruritus, nausea, dizziness	1 hour
SpO2 (%)	SpO2 < 92%	1 hour

Collaborators and Investigators

• Sponsor: Azienda Sanitaria dell'Alto Adige
• Collaborators: Institute of Mountain Emergency Medicine
• Investigators: Principal Investigator: Rosmarie Oberhammer, MD, Südtiroler Sanitätsbetrieb - Bruneck Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 4, 2016
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Fentanyl; Transmucosal administration; Endovenous administration; Pain therapy; Mountain emergency medicine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: SABES Pain 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No