Acute Pain Due to TraumaPhase 4NCT03080350
Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope
A Phase 4 study testing Fentanyl sublingual and Fentanyl ev in people with Acute Pain Due to Trauma, run by Azienda Sanitaria dell'Alto Adige at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain Due to Trauma
- What is being tested?
- Fentanyl sublingual and Fentanyl ev
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma on the limbs with a pain score of 4 or more on the slope
- ASA I - II
Who cannot join
- 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
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- fear of needles
- pregnancy
- speech difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - a Double-blind Randomized Prospective Study
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
Read the 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.
- Conditions
- Acute Pain Due to Trauma
- Being tested
- Fentanyl sublingual, Fentanyl ev, Placebo sublingual, Placebo ev
- Keywords
- Fentanyl, Transmucosal administration, Endovenous administration, Pain therapy, Mountain emergency medicine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl sublingualDrug
Also called Abstral
Fentanyl sublingual
Fentanyl evDrug
Fentanyl ev
Placebo sublingualDrug
Placebo sublingual
Placebo evDrug
Placebo - NaCL 0,9% ev
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl sublingual + Placebo ev | Experimental | Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev Receives: Drug: Fentanyl sublingual; Drug: Placebo ev |
| Fentanyl ev + Placebo sublingual | Active comparator | Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual Receives: Drug: Fentanyl ev; Drug: Placebo sublingual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Relief
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)
Measured: 1 hour
Secondary outcomes (4)
Practicability / handling of the two dosage forms of fentanyl in emergencies
Practicability / handling
Measured: 1 hour
Patient comfort
5 items Labert Scale
Measured: 1 hour
Adverse drug effects
such as pruritus, nausea, dizziness
Measured: 1 hour
SpO2 (%)
SpO2 < 92%
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startJan 2017
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria dell'Alto Adige
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Responsible party
- Principal investigator, Elisabeth Gruber, Azienda Sanitaria dell'Alto Adige
- Investigators
- Rosmarie Oberhammer, MD, Principal investigator, Südtiroler Sanitätsbetrieb - Bruneck Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080350
- Sponsor's protocol ID
- SABES Pain 2
- Status last verified
- Mar 2020
- First submitted
- 4 Dec 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - a Double-blind Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03080350
- Acronym / sponsor ID
- SABES Pain 2
- Conditions
- Acute Pain Due to Trauma
- Keywords
- Fentanyl, Transmucosal administration, Endovenous administration, Pain therapy, Mountain emergency medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Azienda Sanitaria dell'Alto AdigeUniversity, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl sublingual + Placebo ev | Experimental | Drug: Fentanyl sublingual, Drug: Placebo evFentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev |
| Fentanyl ev + Placebo sublingual | Active comparator | Drug: Fentanyl ev, Drug: Placebo sublingualFentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Trauma on the limbs with a pain score of 4 or more on the slope
- ASA I - II
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl sublingualAlso: AbstralFentanyl sublingual | Drug | Fentanyl sublingual + Placebo ev |
| Fentanyl evFentanyl ev | Drug | Fentanyl ev + Placebo sublingual |
| Placebo sublingualPlacebo sublingual | Drug | Fentanyl ev + Placebo sublingual |
| Placebo evPlacebo - NaCL 0,9% ev | Drug | Fentanyl sublingual + Placebo ev |
Primary outcome
Pain - Relief
Time frame: 1 hour
Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)
4 secondary outcomes
Practicability / handling of the two dosage forms of fentanyl in emergencies
Time frame: 1 hour
Patient comfort
Time frame: 1 hour
Adverse drug effects
Time frame: 1 hour
SpO2 (%)
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosmarie Oberhammer, MD principal investigator
Südtiroler Sanitätsbetrieb - Bruneck Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl sublingual and Fentanyl ev in people with Acute Pain Due to Trauma, run by Azienda Sanitaria dell'Alto Adige at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - Relief (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.