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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acute Pain Due to Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fentanyl sublingual + Placebo ev

Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev

Group Type EXPERIMENTAL

Fentanyl sublingual

Intervention Type DRUG

Fentanyl sublingual

Placebo ev

Intervention Type DRUG

Placebo - NaCL 0,9% ev

Fentanyl ev + Placebo sublingual

Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual

Group Type ACTIVE_COMPARATOR

Fentanyl ev

Intervention Type DRUG

Fentanyl ev

Placebo sublingual

Intervention Type DRUG

Placebo sublingual

Interventions

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Fentanyl sublingual

Intervention Type DRUG

Fentanyl ev

Intervention Type DRUG

Placebo sublingual

Intervention Type DRUG

Placebo ev

Placebo - NaCL 0,9% ev

Intervention Type DRUG

Other Intervention Names

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Abstral

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No