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Completed

NCT Number: NCT03080350

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

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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Key information

Conditions

Acute Pain Due to Trauma Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skiresort - Kronplatz

Bruneck, 39031, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl sublingual

Drug

Fentanyl sublingual

Other names: Abstral

Fentanyl ev

Drug

Fentanyl ev

Placebo sublingual

Drug

Placebo sublingual

Placebo ev

Drug

Placebo - NaCL 0,9% ev

Primary outcomes

  1. Pain - Relief

    Time frame: 1 hour

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

Secondary outcomes

  1. Practicability / handling of the two dosage forms of fentanyl in emergencies

    Time frame: 1 hour

    Practicability / handling

  2. Patient comfort

    Time frame: 1 hour

    5 items Labert Scale

  3. Adverse drug effects

    Time frame: 1 hour

    such as pruritus, nausea, dizziness

  4. SpO2 (%)

    Time frame: 1 hour

    SpO2 < 92%

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria dell'Alto Adige

Other

Collaborators

  • Institute of Mountain Emergency Medicine

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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