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

Acute Pain Due to Trauma Clinical Trial

Official title:

Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - a Double-blind Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080350
• Other study ID #: SABES Pain 2
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: March 2018

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 for prehospital analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for patients with limb trauma on the slope

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• 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 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

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
Placebo - NaCL 0,9% ev

Locations

Country	Name	City	State
Italy	Skiresort - Kronplatz	Bruneck

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Sanitaria dell'Alto Adige	Institute of Mountain Emergency Medicine

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