Acute PainNCT02914678
Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting
A study testing Fentanyl in people with Acute Pain, run by University of Aarhus.
Trial summary
In a previous study the investigators evaluated the apparent efficacy and safety of intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4) out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe pain [numeric rating scale (NRS, 0-10) > 3] at… Read more about this study
- Who is it for?
- Ages Up to 110 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,093 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2017
- Phase
- Interventional
- 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 Up to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute pain treated with intravenous fentanyl by ambulance personnel
Who cannot join
- Reduced conscious level (GCS < 15) before initiation of fentanyl treatment
- Reduced respiratory rate (< 10/minute) before initiation of fentanyl treatment
- Patient weight < 30 kg
- Known opioid allergy
- Women in labour
- Chronic pain conditions
About this study
Official title: Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting: A Prospective Cluster-randomized Comparison of 2 vs. 3 μg/kg/Transport
In a previous study the investigators evaluated the apparent efficacy and safety of intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4) out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe pain [numeric rating scale (NRS, 0-10) > 3] at hospital arrival. The number of patients with possible fentanyl-related side effects was low.
Therefore, the aim of the present study is to explore the efficacy and safety of a liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport). The investigators hypothesize that:
- A higher proportion of patients will experience sufficient pain relief at hospital admission (NRS < 4) using the liberalized protocol and
- There will be no differences in the proportion of potential fentanyl related side-effects are observed.
Read the detailed description
A prospective cluster-randomized trial observing proportional differences in sufficient pain relief at hospital admission (NRS < 4) and potential fentanyl related side-effects between patients treated by ambulance personnel applying either:
- a more liberal treatment approach (a total of 3 μg/kg per transport) or
- existing treatment approach (a total of 2 μg/kg per transport).
The Ambulance stations and their affiliated ambulance personnel are stratified into 5 clusters according to size/average transports per month and randomized to either liberal or existing treatment approach within each cluster. As patients are not randomized on an individual level baseline differences between the two groups and its patients are adjusted statistically with relevant confounders on 3 overall levels:
- Patients: Charlson Comorbidity Index Score, main overall diagnose category, inhospital surrogate measures of disease severity (intensive care unit admission and 30-day mortality).
- Ambulance personnel: Years of experience and preinterventional cumulative fentanyl administration and
- Ambulance stations and geographical factors: prehospital time measures and geographical distance from site of emergency to hospital.
These covariates are obtained from the Danish National Patient Registry, the Danish Civil Registration System and the electronic prehospital patient journal.
- Conditions
- Acute Pain
- Being tested
- Fentanyl
- Keywords
- Emergency Medical Services, Analgesics
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylOther
Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport
| Study group | Role | What they receive |
|---|---|---|
| Existing treatment | No intervention | Business as usual: Ambulance personnel use existing treatment approach (a total of 2 μg/kg fentanyl per transport) |
| More liberal treatment | Experimental | Ambulance personnel use a more liberal treatment approach (a total of 3 μg/kg fentanyl per transport) Receives: Other: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival
Measured: Up to 6 hours
Secondary outcomes (4)
Proportion of patients with reduced Glasgow Coma Scale (<15) after fentanyl administration and at any given point during transport
Measured: Up to 6 hours
Proportion of patients with reduced respiratory rate (<10/minute) after fentanyl administration and at any given point during transport
Measured: Up to 6 hours
Proportion of patients with reduced peripheral oxygen saturation (< 90%) after fentanyl administration and at any given point during transport
Measured: Up to 6 hours
Proportion of patients with hypotension after fentanyl administration and at any given point during transport
Hypotension defined as a drop in mean arterial pressure (MAP) >= 10 mmHg to a MAP < 70 mmHg
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Kristian Friesgaard, MD, PhD Student, Principal investigator, University of AarhusLone Nikolajsen, DmSc, Study chair, Aarhus University HospitalHans Kirkegaard, Professor, Study chair, Aarhus University HospitalErika Frischknecht Christensen, Professor, Study chair, North Denmark RegionMatthias Giebner, MD, Study chair, Central Denmark RegionClaus-Henrik Rasmussen, MD, Study chair, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914678
- Sponsor's protocol ID
- AU-PHA2V3
- Status last verified
- Oct 2017
- First submitted
- 12 Sep 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Friesgaard KD, Nikolajsen L, Giebner M, Rasmussen CH, Riddervold IS, Kirkegaard H, Christensen EF. Efficacy and safety of intravenous fentanyl administered by ambulance personnel. Acta Anaesthesiol Scand. 2016 Apr;60(4):537-43. doi: 10.1111/aas.12662. Epub 2015 Nov 27.
PubMed 26612100Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011 Jul;39(7 Suppl):30-3. doi: 10.1177/1403494811401482.
PubMed 21775347Schmidt M, Pedersen L, Sorensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014 Aug;29(8):541-9. doi: 10.1007/s10654-014-9930-3. Epub 2014 Jun 26.
PubMed 24965263Friesgaard KD, Kirkegaard H, Rasmussen CH, Giebner M, Christensen EF, Nikolajsen L. Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols. Scand J Trauma Resusc Emerg Med. 2019 Feb 7;27(1):11. doi: 10.1186/s13049-019-0588-4.
PubMed 30732618
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting: A Prospective Cluster-randomized Comparison of 2 vs. 3 μg/kg/Transport
- ClinicalTrials.gov ID
- NCT02914678
- Acronym / sponsor ID
- AU-PHA2V3
- Conditions
- Acute Pain
- Keywords
- Emergency Medical Services, Analgesics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,093 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Sep 2016 (estimated)
- 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.
In a previous study the investigators evaluated the apparent efficacy and safety of intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4) out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe pain [numeric rating scale (NRS, 0-10) > 3] at hospital arrival. The number of patients with possible fentanyl-related side effects was low.
Therefore, the aim of the present study is to explore the efficacy and safety of a liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport). The investigators hypothesize that:
- A higher proportion of patients will experience sufficient pain relief at hospital admission (NRS < 4) using the liberalized protocol and
- There will be no differences in the proportion of potential fentanyl related side-effects are observed.
Detailed description
A prospective cluster-randomized trial observing proportional differences in sufficient pain relief at hospital admission (NRS < 4) and potential fentanyl related side-effects between patients treated by ambulance personnel applying either:
- a more liberal treatment approach (a total of 3 μg/kg per transport) or
- existing treatment approach (a total of 2 μg/kg per transport).
The Ambulance stations and their affiliated ambulance personnel are stratified into 5 clusters according to size/average transports per month and randomized to either liberal or existing treatment approach within each cluster. As patients are not randomized on an individual level baseline differences between the two groups and its patients are adjusted statistically with relevant confounders on 3 overall levels:
- Patients: Charlson Comorbidity Index Score, main overall diagnose category, inhospital surrogate measures of disease severity (intensive care unit admission and 30-day mortality).
- Ambulance personnel: Years of experience and preinterventional cumulative fentanyl administration and
- Ambulance stations and geographical factors: prehospital time measures and geographical distance from site of emergency to hospital.
These covariates are obtained from the Danish National Patient Registry, the Danish Civil Registration System and the electronic prehospital patient journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Existing treatment | No intervention | –Business as usual: Ambulance personnel use existing treatment approach (a total of 2 μg/kg fentanyl per transport) |
| More liberal treatment | Experimental | Other: FentanylAmbulance personnel use a more liberal treatment approach (a total of 3 μg/kg fentanyl per transport) |
Who may qualify
- Ages
- Up to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute pain treated with intravenous fentanyl by ambulance personnel
Key exclusion criteria (6 listed)
- Reduced conscious level (GCS < 15) before initiation of fentanyl treatment
- Reduced respiratory rate (< 10/minute) before initiation of fentanyl treatment
- Patient weight < 30 kg
- Known opioid allergy
- Women in labour
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 |
|---|---|---|
| FentanylChange in protocol from 2 to a total of 3 μg/kg fentanyl per transport | Other | More liberal treatment |
Primary outcome
Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival
Time frame: Up to 6 hours
4 secondary outcomes
Proportion of patients with reduced Glasgow Coma Scale (<15) after fentanyl administration and at any given point during transport
Time frame: Up to 6 hours
Proportion of patients with reduced respiratory rate (<10/minute) after fentanyl administration and at any given point during transport
Time frame: Up to 6 hours
Proportion of patients with reduced peripheral oxygen saturation (< 90%) after fentanyl administration and at any given point during transport
Time frame: Up to 6 hours
Proportion of patients with hypotension after fentanyl administration and at any given point during transport
Time frame: Up to 6 hours
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 27 Oct 2017.
- Background: PubMed 26612100Friesgaard KD, Nikolajsen L, Giebner M, Rasmussen CH, Riddervold IS, Kirkegaard H, Christensen EF. Efficacy and safety of intravenous fentanyl administered by ambulance personnel. Acta Anaesthesiol Scand. 2016 Apr;60(4):537-43. doi: 10.1111/aas.12662. Epub 2015 Nov 27.
- Background: PubMed 21775347Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011 Jul;39(7 Suppl):30-3. doi: 10.1177/1403494811401482.
- Background: PubMed 24965263Schmidt M, Pedersen L, Sorensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014 Aug;29(8):541-9. doi: 10.1007/s10654-014-9930-3. Epub 2014 Jun 26.
- Derived from this study: PubMed 30732618Friesgaard KD, Kirkegaard H, Rasmussen CH, Giebner M, Christensen EF, Nikolajsen L. Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols. Scand J Trauma Resusc Emerg Med. 2019 Feb 7;27(1):11. doi: 10.1186/s13049-019-0588-4.
- Individual participant dataSharing planned: No
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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.
Kristian Friesgaard, MD, PhD Student principal investigator
University of Aarhus
Lone Nikolajsen, DmSc study chair
Aarhus University Hospital
Hans Kirkegaard, Professor study chair
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl in people with Acute Pain, run by University of Aarhus.
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 1 inclusion and 6 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914678, which also lists 4 linked publications.
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 27 Oct 2017.