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Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols

BACKGROUND: Prehospital acute pain is a frequent symptom that is often inadequately managed. The concerns of opioid induced side effects are well-founded. To ensure patient safety, ambulance personnel are therefore provided with treatment protocols with dosing restrictions, however, with the concomi...

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Autores principales: Friesgaard, Kristian D., Kirkegaard, Hans, Rasmussen, Claus-Henrik, Giebner, Matthias, Christensen, Erika F., Nikolajsen, Lone
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6367789/
https://www.ncbi.nlm.nih.gov/pubmed/30732618
http://dx.doi.org/10.1186/s13049-019-0588-4
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author Friesgaard, Kristian D.
Kirkegaard, Hans
Rasmussen, Claus-Henrik
Giebner, Matthias
Christensen, Erika F.
Nikolajsen, Lone
author_facet Friesgaard, Kristian D.
Kirkegaard, Hans
Rasmussen, Claus-Henrik
Giebner, Matthias
Christensen, Erika F.
Nikolajsen, Lone
author_sort Friesgaard, Kristian D.
collection PubMed
description BACKGROUND: Prehospital acute pain is a frequent symptom that is often inadequately managed. The concerns of opioid induced side effects are well-founded. To ensure patient safety, ambulance personnel are therefore provided with treatment protocols with dosing restrictions, however, with the concomitant risk of insufficient pain treatment of the patients. The aim of this study was to investigate the impact of a liberal intravenous fentanyl treatment protocol on efficacy and safety measures. METHODS: A two-armed, cluster-randomised trial was conducted in the Central Denmark Region over a 1-year period. Ambulance stations (stratified according to size) were randomised to follow either a liberal treatment protocol (3 μg/kg) or a standard treatment protocol (2 μg/kg). The primary outcome was the proportion of patients with sufficient pan relief (numeric rating scale (NRS, 0–10) < 3) at hospital arrival. Secondary outcomes included abnormal vital parameters as proxy measures of safety. A multi-level mixed effect logistic regression model was applied. RESULTS: In total, 5278 patients were included. Ambulance personnel following the liberal protocol administered higher doses of fentanyl [117.7 μg (95% CI 116.7–118.6)] than ambulance personnel following the standard protocol [111.5 μg (95% CI 110.7–112.4), P = 0.0001]. The number of patient with sufficient pain relief at hospital arrival was higher in the liberal treatment group than the standard treatment group [44.0% (95% CI 41.8–46.1) vs. 37.4% (95% CI 35.2–39.6), adjusted odds ratio 1.47 (95% CI 1.17–1.84)]. The relative decrease in NRS scores during transport was less evident [adjusted odds ratio 1.18 (95% CI 0.95–1.48)]. The occurrences of abnormal vital parameters were similar in both groups. CONCLUSIONS: Liberalising an intravenous fentanyl treatment protocol applied by ambulance personnel slightly increased the number of patients with sufficient pain relief at hospital arrival without compromising patient safety. Future efforts of training ambulance personnel are needed to further improve protocol adherence and quality of treatment. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02914678). Date of registration: 26th September, 2016.
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spelling pubmed-63677892019-02-15 Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols Friesgaard, Kristian D. Kirkegaard, Hans Rasmussen, Claus-Henrik Giebner, Matthias Christensen, Erika F. Nikolajsen, Lone Scand J Trauma Resusc Emerg Med Original Research BACKGROUND: Prehospital acute pain is a frequent symptom that is often inadequately managed. The concerns of opioid induced side effects are well-founded. To ensure patient safety, ambulance personnel are therefore provided with treatment protocols with dosing restrictions, however, with the concomitant risk of insufficient pain treatment of the patients. The aim of this study was to investigate the impact of a liberal intravenous fentanyl treatment protocol on efficacy and safety measures. METHODS: A two-armed, cluster-randomised trial was conducted in the Central Denmark Region over a 1-year period. Ambulance stations (stratified according to size) were randomised to follow either a liberal treatment protocol (3 μg/kg) or a standard treatment protocol (2 μg/kg). The primary outcome was the proportion of patients with sufficient pan relief (numeric rating scale (NRS, 0–10) < 3) at hospital arrival. Secondary outcomes included abnormal vital parameters as proxy measures of safety. A multi-level mixed effect logistic regression model was applied. RESULTS: In total, 5278 patients were included. Ambulance personnel following the liberal protocol administered higher doses of fentanyl [117.7 μg (95% CI 116.7–118.6)] than ambulance personnel following the standard protocol [111.5 μg (95% CI 110.7–112.4), P = 0.0001]. The number of patient with sufficient pain relief at hospital arrival was higher in the liberal treatment group than the standard treatment group [44.0% (95% CI 41.8–46.1) vs. 37.4% (95% CI 35.2–39.6), adjusted odds ratio 1.47 (95% CI 1.17–1.84)]. The relative decrease in NRS scores during transport was less evident [adjusted odds ratio 1.18 (95% CI 0.95–1.48)]. The occurrences of abnormal vital parameters were similar in both groups. CONCLUSIONS: Liberalising an intravenous fentanyl treatment protocol applied by ambulance personnel slightly increased the number of patients with sufficient pain relief at hospital arrival without compromising patient safety. Future efforts of training ambulance personnel are needed to further improve protocol adherence and quality of treatment. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02914678). Date of registration: 26th September, 2016. BioMed Central 2019-02-07 /pmc/articles/PMC6367789/ /pubmed/30732618 http://dx.doi.org/10.1186/s13049-019-0588-4 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Original Research
Friesgaard, Kristian D.
Kirkegaard, Hans
Rasmussen, Claus-Henrik
Giebner, Matthias
Christensen, Erika F.
Nikolajsen, Lone
Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols
title Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols
title_full Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols
title_fullStr Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols
title_full_unstemmed Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols
title_short Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols
title_sort prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6367789/
https://www.ncbi.nlm.nih.gov/pubmed/30732618
http://dx.doi.org/10.1186/s13049-019-0588-4
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