PAin SoluTions In the Emergency Setting (PASTIES)—patient controlled analgesia versus routine care in emergency department patients with pain from traumatic injuries: randomised trial
BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2988 (Published 21 June 2015) Cite this as: BMJ 2015;350:h2988
- Jason E Smith, consultant in emergency medicine1, defence professor of emergency medicine2, honorary professor3,
- Mark Rockett, consultant in anaesthesia and pain medicine1, associate professor3,
- Siobhan Creanor S, associate professor (senior lecturer) in health statistics4,
- Rosalyn Squire, research nurse1,
- Chris Hayward, senior trial manager5,
- Paul Ewings, director6,
- Andy Barton, consultant6,
- Colin Pritchard, consultant6,
- Victoria Eyre, trial manager5,
- Laura Cocking, senior data manager5,
- Jonathan Benger, professor of emergency care7
- on behalf of the PASTIES research team
- 1Derriford Hospital, Plymouth PL6 8DH, UK
- 2Academic Department of Military Emergency Medicine, Royal Centre for Defence Medicine (Research and Academia), Medical Directorate, Birmingham, UK
- 3Centre for Clinical Trials and Population Studies, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK
- 4Centre for Biostatistics, Bioinformatics and Biomarkers, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK
- 5Peninsula Clinical Trials Unit, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK
- 6NIHR Research Design Service - South West
- 7Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK
- Correspondence to: J Smith jasonesmith{at}nhs.net
- Accepted 8 May 2015
Abstract
Objective To determine whether patient controlled analgesia (PCA) is better than routine care in patients presenting to emergency departments with moderate to severe pain from traumatic injuries.
Design Pragmatic, multicentre, parallel group, randomised controlled trial.
Setting Five English hospitals.
Participants 200 adults (71% (n=142) male), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe pain from traumatic injuries and were expected to be admitted to hospital for at least 12 hours.
Interventions PCA (n=99) or nurse titrated analgesia (treatment as usual; n=101).
Main outcome measures The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant’s hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate/severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management.
Results 200 participants were included in the primary analyses. Mean total pain experienced was 47.2 (SD 21.9) for the treatment as usual group and 44.0 (24.0) for the PCA group. Adjusted analyses indicated slightly (but not statistically significantly) lower total pain experienced in the PCA group than in the routine care group (mean difference 2.7, 95% confidence interval −2.4 to 7.8). Participants allocated to PCA used more morphine in total than did participants in the treatment as usual group (mean 44.3 (23.2) v 27.2 (18.2) mg; mean difference 17.0, 11.3 to 22.7). PCA participants spent, on average, less time in moderate/severe pain (36.2% (31.0) v 44.1% (31.6)), but the difference was not statistically significant. A higher proportion of PCA participants reported being perfectly or very satisfied compared with the treatment as usual group (86% (78/91) v 76% (74/98)), but this was also not statistically significant.
Conclusions PCA provided no statistically significant reduction in pain compared with routine care for emergency department patients with traumatic injuries.
Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.
Footnotes
We acknowledge the support of the National Institute for Health Research, through the Comprehensive Clinical Research Network. We are grateful for the help and support of the PASTIES research team, who include the following. Principal investigators: Andrew Appelboam, Jason Kendall, Tim Harris, and Tim Coats; Trial Steering Committee: Clifford Mann, Jason Kendall, Chris Rollinson, Hamish McPhie (patient representative), and Karen Higginson (patient representative); Data Monitoring Committee: Suzanne Mason, Lesley Colvin, and Chris Metcalfe; Plymouth team: Katy Pereira, Nicola Scholes, Fiona Haddon, Stuart Quarterman, Rae Morgan, Anthony Kehoe, and Simon Horne. Exeter team: Steve Harvey, Jennie Small, and Caroline Renton; Bristol team: Vanessa Lawlor, Emmy Oldenbourg, Hannah Skuse, Anna Gilbertson, David Rea, Sarah Hierons, Ruth Worner, Vicki Williams, and Stephanie Lambert; London team: Jason Pott, Nicola Harvey, Geoffrey Bellhouse, Imogen Skene, Ben Bloom, and Mihai Chiriac; Leicester team: Rachel Lock and Catriona Bryceland.
Contributors: JES conceived the study, was the chief investigator, and co-wrote the initial manuscript. MR and RS co-wrote the initial protocol and were involved with the conduct of the study. CH was the initial trial manager and helped to develop the study protocol to its final version. PE, AB, and CP gave methodological advice, edited the final protocol, and edited versions of this manuscript. SC was the trial statistician, was involved in conduct of the study from its inception, and contributed to the manuscript. VE took over as trial manager during the study. LC was the data manager and helped to draft the results. JB contributed to the initial and final drafts of the protocol and provided advice on patient recruitment and the effective conduct of the study. All authors contributed to and approved the final manuscript. JES is the guarantor.
Funding: This research was funded by the National Institute for Health Research (NIHR)’s research for patient benefit programme, grant reference number PB-PG-0909-20048. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work other than that described above; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study was approved by the South Central-Southampton A Research Ethics Committee (REC reference 11/SC/0151).
Transparency statement: The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Data sharing: Patient level data are stored in the PASTIES database, developed by the Peninsula Clinical Trials Unit on a secure server maintained by Plymouth University. Presented data are fully anonymised. No consent for data sharing with other parties was obtained, but the corresponding author may be contacted to forward requests for data sharing.
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