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

Primary Purpose

Acute Pain Due to Trauma

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Fentanyl sublingual
Fentanyl ev
Placebo sublingual
Placebo ev
Sponsored by
Azienda Sanitaria dell'Alto Adige
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain Due to Trauma focused on measuring Fentanyl, Transmucosal administration, Endovenous administration, Pain therapy, Mountain emergency medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Skiresort - Kronplatz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fentanyl sublingual + Placebo ev

Fentanyl ev + Placebo sublingual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain - Relief
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
Practicability / handling
Patient comfort
5 items Labert Scale
Adverse drug effects
such as pruritus, nausea, dizziness
SpO2 (%)
SpO2 < 92%

Full Information

First Posted
December 4, 2016
Last Updated
March 1, 2020
Sponsor
Azienda Sanitaria dell'Alto Adige
Collaborators
Institute of Mountain Emergency Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03080350
Brief Title
Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope
Official Title
Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - a Double-blind Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Sanitaria dell'Alto Adige
Collaborators
Institute of Mountain Emergency Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain Due to Trauma
Keywords
Fentanyl, Transmucosal administration, Endovenous administration, Pain therapy, Mountain emergency medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl sublingual + Placebo ev
Arm Type
Experimental
Arm Description
Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev
Arm Title
Fentanyl ev + Placebo sublingual
Arm Type
Active Comparator
Arm Description
Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual
Intervention Type
Drug
Intervention Name(s)
Fentanyl sublingual
Other Intervention Name(s)
Abstral
Intervention Description
Fentanyl sublingual
Intervention Type
Drug
Intervention Name(s)
Fentanyl ev
Intervention Description
Fentanyl ev
Intervention Type
Drug
Intervention Name(s)
Placebo sublingual
Intervention Description
Placebo sublingual
Intervention Type
Drug
Intervention Name(s)
Placebo ev
Intervention Description
Placebo - NaCL 0,9% ev
Primary Outcome Measure Information:
Title
Pain - Relief
Description
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Practicability / handling of the two dosage forms of fentanyl in emergencies
Description
Practicability / handling
Time Frame
1 hour
Title
Patient comfort
Description
5 items Labert Scale
Time Frame
1 hour
Title
Adverse drug effects
Description
such as pruritus, nausea, dizziness
Time Frame
1 hour
Title
SpO2 (%)
Description
SpO2 < 92%
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosmarie Oberhammer, MD
Organizational Affiliation
Südtiroler Sanitätsbetrieb - Bruneck Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skiresort - Kronplatz
City
Bruneck
ZIP/Postal Code
39031
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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