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

Acute Pain Due to Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080324
• Other study ID #: SABES 1
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2016
• Est. completion date: May 15, 2017

Study information

• Verified date: March 2020
• Source: Azienda Sanitaria dell'Alto Adige
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Wounds and Injuries

Intervention

Drug:
• Fentanyl sublingual
Fentanyl sublingual
• Fentanyl ev
Fentanyl ev
• Placebo sublingual
Placebo sublingual
• Placebo ev
Saline

Locations

Country	Name	City	State
Italy	Emergency Room of Bruneck Regional Hospital	Bruneck

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria dell'Alto Adige

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain - Relief	Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)	1 hour
Secondary	Practicability / handling of the two dosage forms of fentanyl in emergencies	Practicability / handling	1 hour
Secondary	Patient comfort	5 items Labert Scale	1 hour
Secondary	Adverse drug effects	such as pruritus, nausea, dizziness	1 hour
Secondary	SpO2 (%)	SpO2 < 92%	1 hour