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

Sponsor

Azienda Sanitaria dell'Alto Adige (Other)

Overall Status

Completed

CT.gov ID

NCT03080350

Collaborator

Institute of Mountain Emergency Medicine (Other)

108

Enrollment

Location

Arms

13.9

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Due to Trauma	Drug: Fentanyl sublingual Drug: Fentanyl ev Drug: Placebo sublingual Drug: Placebo ev	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain - Relief [1 hour]
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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