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Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room

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

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
  • ASA I - II

Exclusion Criteria:

  • children < 18 years
  • cognitive impairment: brain injury, intoxication, analgesia
  • weight under 50 kg and more then 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

  • Emergency Room of Bruneck Regional Hospital

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
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1. Study Identification

Unique Protocol Identification Number
NCT03080324
Brief Title
Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room
Official Title
Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the ER - a Double-blind Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Sanitaria dell'Alto Adige

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 of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.
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 pain relief in oncologic patients. The immediate (10 minutes) effect and the ease of administration of sublingual fentanyl could be a possibility for a fast pain relief in remote areas such as mountain rescue missions. 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

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
Other Intervention Name(s)
Fentanest
Intervention Description
Fentanyl ev
Intervention Type
Drug
Intervention Name(s)
Placebo sublingual
Other Intervention Name(s)
Placebo
Intervention Description
Placebo sublingual
Intervention Type
Drug
Intervention Name(s)
Placebo ev
Other Intervention Name(s)
Saline
Intervention Description
Saline
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 ASA I - II Exclusion Criteria: children < 18 years cognitive impairment: brain injury, intoxication, analgesia weight under 50 kg and more then 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
Elisabeth Gruber, MG MSc
Organizational Affiliation
Südtiroeler Sanitätsbetrieb
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Room of Bruneck Regional Hospital
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 Pain Treatment in Trauma Patients in the Emergency Room

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