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

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

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.

Related collections

Most cited references 63

Record: found
Abstract: found
Article: not found

How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance

Gillian Heller, Maurizio Manuguerra, Roberta Chow (2016)

The Visual Analogue Scale (VAS) is a popular tool for the measurement of pain. A variety of statistical methods are employed for its analysis as an outcome measure, not all of them optimal or appropriate. An issue which has attracted much discussion in the literature is whether VAS is at a ratio or ordinal level of measurement. This decision has an influence on the appropriate method of analysis. The aim of this article is to provide an overview of current practice in the analysis of VAS scores, to propose a method of analysis which avoids the shortcomings of more traditional approaches, and to provide best practice recommendations for the analysis of VAS scores. We report on the current usage of statistical methods, which fall broadly into two categories: those that assume a probability distribution for VAS, and those that do not. We give an overview of these methods, and propose continuous ordinal regression, an extension of current ordinal regression methodology, which is appropriate for VAS at an ordinal level of measurement. We demonstrate the analysis of a published data set using a variety of methods, and use simulation to compare the power of the various methods to detect treatment differences, in differing pain situations. We demonstrate that continuous ordinal regression provides the most powerful statistical analysis under a variety of conditions. We recommend that in the situation in which no covariates besides treatment group are included in the analysis, distribution-free methods (Wilcoxon, Mann–Whitney) be used, as their power is indistinguishable from that of the proposed method. In the situation in which there are covariates which affect VAS, the proposed method is optimal. However, in this case, if the VAS scores are not concentrated around either extreme of the scale, normal-distribution methods ( t -test, linear regression) are almost as powerful, and are recommended as a pragmatic choice. In the case of small sample size and VAS skewed to either extreme of the scale, the proposed method has vastly superior power to other methods.

0 comments Cited 133 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

Is Open Access

Implementing a nationwide criteria-based emergency medical dispatch system: A register-based follow-up study

Mikkel S Andersen, Søren Paaske Johnsen, Jan Sørensen … (2013)

Background A criteria-based nationwide Emergency Medical Dispatch (EMD) system was recently implemented in Denmark. We described the system and studied its ability to triage patients according to the severity of their condition by analysing hospital admission and case-fatality risks. Methods This was a register-based follow-up study of all 1-1-2 calls in a 6-month period that were triaged according to the Danish Index – the new criteria-based dispatch protocol. Danish Index data were linked with hospital and vital status data from national registries. Confidence intervals (95%) for proportions with binomial data were computed using exact methods. To test for trend the Wald test was used. Results Information on level of emergency according to the Danish Index rating was available for 67,135 patients who received ambulance service. Emergency level A (urgent cases) accounted for 51.4% (n = 34,489) of patients, emergency level B for 46.3% (n = 31,116), emergency level C for 2.1% (n = 1,391) and emergency level D for 0.2% (n = 139). For emergency level A, the median time from call receipt to ambulance dispatch was 2 min 1 s, and the median time to arrival was 6 min 11 s. Data concerning admission and case fatality was available for 55,270 patients. The hospital admission risk for emergency level A patients was 64.4% (95% CI = 63.8-64.9). There was a significant trend (p < 0.001) towards lower admission risks for patients with lower levels of emergency. The case fatality risk for emergency level A patients on the same day as the 1-1-2 call was 4.4% (95% CI = 4.1-4.6). The relative case-fatality risk among emergency level A patients compared to emergency level B–D patients was 14.3 (95% CI: 11.5-18.0). Conclusion The majority of patients were assessed as Danish Index emergency level A or B. Case fatality and hospital admission risks were substantially higher for emergency level A patients than for emergency level B–D patients. Thus, the newly implemented Danish criteria-based dispatch system seems to triage patients with high risk of admission and death to the highest level of emergency. Further studies are needed to determine the degree of over- and undertriage and prognostic factors.

0 comments Cited 71 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data.

N Cashman, Lev S Dolin (2004)

This study examines the evidence from published data concerning the adverse respiratory and haemodynamic effects of three analgesic techniques after major surgery; i.m. analgesia, patient-controlled analgesia (PCA), and epidural analgesia. A MEDLINE search of the literature was conducted for publications concerned with the management of postoperative pain. Information relating to variables indicative of respiratory depression and of hypotension was extracted from these studies. Over 800 original papers and reviews were identified. Of these papers, 212 fulfilled the inclusion criteria but only 165 provided usable data on adverse effects. Pooled data obtained from these studies, which represent the experience of a total of nearly 20,000 patients, form the basis of this study. There was considerable variability between studies in the criteria used for defining respiratory depression and hypotension. The overall mean (95% CI) incidence of respiratory depression of the three analgesic techniques was: 0.3 (0.1-1.3)% using requirement for naloxone as an indicator; 1.1 (0.7-1.7)% using hypoventilation as an indicator; 3.3 (1.4-7.6)% using hypercarbia as an indicator; and 17.0 (10.2-26.9)% using oxygen desaturation as an indicator. For i.m. analgesia, the mean (95% CI) reported incidence of respiratory depression varied between 0.8 (0.2-2.5) and 37.0 (22.6-45.9)% using hypoventilation and oxygen desaturation, respectively, as indicators. For PCA, the mean (95% CI) reported incidence of respiratory depression varied between 1.2 (0.7-1.9) and 11.5 (5.6-22.0)%, using hypoventilation and oxygen desaturation, respectively, as indicators. For epidural analgesia, the mean (95% CI) reported incidence of respiratory depression varied between 1.1 (0.6-1.9) and 15.1 (5.6-34.8)%, using hypoventilation and oxygen desaturation, respectively, as indicators. The mean (95% CI) reported incidence of hypotension for i.m. analgesia was 3.8 (1.9-7.5)%, for PCA 0.4 (0.1-1.9)%, and for epidural analgesia 5.6 (3.0-10.2)%. Whereas the incidence of respiratory depression decreased over the period 1980-99, the incidence of hypotension did not. Assuming a mixture of analgesic techniques, Acute Pain Services should expect an incidence of respiratory depression, as defined by a low ventilatory frequency, of less than 1%, and an incidence of hypotension related to analgesic technique of less than 5%.

0 comments Cited 60 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Kristian D. Friesgaard: k.friesgaard@me.com

Hans Kirkegaard: hanskirkegaard@dadlnet.dk

Claus-Henrik Rasmussen: chr@midtonline.com

Matthias Giebner: matthias.giebner@rsyd.dk

Erika F. Christensen: efc@rn.dk

Lone Nikolajsen: lone.nikolajsen@clin.au.dk

Journal

Journal ID (nlm-ta): Scand J Trauma Resusc Emerg Med

Journal ID (iso-abbrev): Scand J Trauma Resusc Emerg Med

Title: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

Publisher: BioMed Central (London )

ISSN (Electronic): 1757-7241

Publication date (Electronic): 7 February 2019

Publication date PMC-release: 7 February 2019

Publication date Collection: 2019

Volume: 27

Electronic Location Identifier: 11

Affiliations

[1 ]Research Department, Prehospital Emergency Medical Service, Central Denmark Region, Olof Palmes Allé 34, 8200 Aarhus N, Denmark

[2 ]ISNI 0000 0004 0646 9002, GRID grid.414334.5, Department of Anaesthesiology, , Regional Hospital of Horsens, ; Horsens, Denmark

[3 ]Falck Danmark A/S, Central Denmark Region, Aarhus, Denmark

[4 ]Response A/S, Central Denmark Region, Hedensted, Denmark

[5 ]ISNI 0000 0001 0742 471X, GRID grid.5117.2, Department of Clinical Medicine, Prehospital and Emergency Research, , Aalborg University, ; Aalborg, Denmark

[6 ]ISNI 0000 0004 0646 7349, GRID grid.27530.33, Department of Anaesthesiology and Intensive Care, , Emergency Clinic Aalborg University Hospital, ; Aalborg, Denmark

[7 ]ISNI 0000 0004 0512 597X, GRID grid.154185.c, Department of Anaesthesiology and Intensive Care, , Aarhus University Hospital, ; Aarhus, Denmark

Article

Publisher ID: 588

DOI: 10.1186/s13049-019-0588-4

PMC ID: 6367789

PubMed ID: 30732618

SO-VID: 9c1cc064-a1b5-40e5-ab0a-5f89d424b5ec

License:

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.