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

Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the ER - a Double-blind Randomized Prospective Study

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.

Study Overview

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

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 pain relief in oncologic patients.

The immediate (10 minutes) effect and the ease of administration of sublingual fentanyl could be a possibility for a fast pain relief in remote areas such as mountain rescue missions.

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
    • Emergency Room of Bruneck Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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
• ASA I - II

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• 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; Saline; Other Names: Saline
ACTIVE_COMPARATOR: Fentanyl ev + Placebo sublingual; Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual	Drug: Fentanyl ev; Fentanyl ev; Other Names: Fentanest; Drug: Placebo sublingual; Placebo sublingual; Other Names: Placebo

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
• Investigators: Principal Investigator: Elisabeth Gruber, MG MSc, Südtiroeler Sanitätsbetrieb

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): May 15, 2017
• Study Completion (ACTUAL): May 15, 2017

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
• 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 1

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