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Published in: BMC Health Services Research 1/2018

Open Access 01-12-2018 | Research article

Patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement; a randomised controlled trial

Authors: Katherine H. O. Deane, Richard Gray, Paula Balls, Clare Darrah, Louise Swift, Alan B. Clark, Garry R. Barton, Sophie Morris, Sue Butters, Angela Bullough, Helen Flaherty, Barbara Talbot, Mark Sanders, Simon T. Donell

Published in: BMC Health Services Research | Issue 1/2018

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Abstract

Background

Self-administration of medicines by patients whilst in hospital is being increasingly promoted despite little evidence to show the risks and benefits. Pain control after total knee replacement (TKR) is known to be poor.
The aim of the study was to determine if patients operated on with a TKR who self-medicate their oral analgesics in the immediate post-operative period have better pain control than those who receive their pain control by nurse-led drug rounds (Treatment as Usual (TAU)).

Methods

A prospective, parallel design, open-label, randomised controlled trial comparing pain control in patient-directed self-management of pain (PaDSMaP) with nurse control of oral analgesia (TAU) after a TKR. Between July 2011 and March 2013, 144 self-medicating adults were recruited at a secondary care teaching hospital in the UK. TAU patients (n = 71) were given medications by a nurse after their TKR. PaDSMaP patients (n = 73) took oral medications for analgesia and co-morbidities after two 20 min training sessions reinforced with four booklets. Primary outcome was pain (100 mm visual analogue scale (VAS)) at 3 days following TKR surgery or at discharge (whichever came soonest). Seven patients did not undergo surgery for reasons unrelated to the study and were excluded from the intention-to-treat (ITT) analysis.

Results

ITT analysis did not detect any significant differences between the two groups’ pain scores. A per protocol (but underpowered) analysis of the 60% of patients able to self-medicate found reduced pain compared to the TAU group at day 3/discharge, (VAS -9.9 mm, 95% CI -18.7, − 1.1). One patient in the self-medicating group over-medicated but suffered no harm.

Conclusion

Self-medicating patients did not have better (lower) pain scores compared to the nurse-managed patients following TKR. This cohort of patients were elderly with multiple co-morbidities and may not be the ideal target group for self-medication.

Trial Registration

ISRCTN10868989. Registered 22 March 2012, retrospectively registered.
Appendix
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Metadata
Title
Patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement; a randomised controlled trial
Authors
Katherine H. O. Deane
Richard Gray
Paula Balls
Clare Darrah
Louise Swift
Alan B. Clark
Garry R. Barton
Sophie Morris
Sue Butters
Angela Bullough
Helen Flaherty
Barbara Talbot
Mark Sanders
Simon T. Donell
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2018
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/s12913-018-3146-2

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