Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting
NCT ID: NCT02914678
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7093 participants
INTERVENTIONAL
2016-10-31
2017-10-31
Brief Summary
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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
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* 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:
1. Patients: Charlson Comorbidity Index Score, main overall diagnose category, inhospital surrogate measures of disease severity (intensive care unit admission and 30-day mortality).
2. Ambulance personnel: Years of experience and preinterventional cumulative fentanyl administration and
3. 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Existing treatment
Business as usual: Ambulance personnel use existing treatment approach (a total of 2 μg/kg fentanyl per transport)
No interventions assigned to this group
More liberal treatment
Ambulance personnel use a more liberal treatment approach (a total of 3 μg/kg fentanyl per transport)
Fentanyl
Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport
Interventions
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Fentanyl
Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Reduced respiratory rate (\< 10/minute) before initiation of fentanyl treatment
* Patient weight \< 30 kg
* Known opioid allergy
* Women in labour
* Chronic pain conditions
110 Years
ALL
No
Sponsors
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Central Denmark Region
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Kristian Friesgaard, MD, PhD Student
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Lone Nikolajsen, DmSc
Role: STUDY_CHAIR
Aarhus University Hospital
Hans Kirkegaard, Professor
Role: STUDY_CHAIR
Aarhus University Hospital
Erika Frischknecht Christensen, Professor
Role: STUDY_CHAIR
North Denmark Region
Matthias Giebner, MD
Role: STUDY_CHAIR
Central Denmark Region
Claus-Henrik Rasmussen, MD
Role: STUDY_CHAIR
Central Denmark Region
References
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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.
Lynge 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.
Schmidt 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.
Friesgaard 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.
Other Identifiers
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AU-PHA2V3
Identifier Type: -
Identifier Source: org_study_id