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SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt
OBJECTIVES: Sickle With Ibuprofen and Morphine (SWIM) trial was designed to assess whether co-administration of ibuprofen (a non-steroidal anti-inflammatory drug) resulted in a reduction of opioid consumption delivered by patient-controlled analgesia (PCA) for acute pain in sickle cell disease. DESI...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4908891/ https://www.ncbi.nlm.nih.gov/pubmed/27288381 http://dx.doi.org/10.1136/bmjopen-2016-011276 |
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author | Cho, Gavin Anie, Kofi A Buckton, Jacky Kiilu, Patricia Layton, Mark Alexander, Lydia Hemmaway, Claire Sutton, Dorothy Amos, Claire Doré, Caroline J Kahan, Brennan Meredith, Sarah |
author_facet | Cho, Gavin Anie, Kofi A Buckton, Jacky Kiilu, Patricia Layton, Mark Alexander, Lydia Hemmaway, Claire Sutton, Dorothy Amos, Claire Doré, Caroline J Kahan, Brennan Meredith, Sarah |
author_sort | Cho, Gavin |
collection | PubMed |
description | OBJECTIVES: Sickle With Ibuprofen and Morphine (SWIM) trial was designed to assess whether co-administration of ibuprofen (a non-steroidal anti-inflammatory drug) resulted in a reduction of opioid consumption delivered by patient-controlled analgesia (PCA) for acute pain in sickle cell disease. DESIGN: A randomised, placebo-controlled, double-blind trial. SETTING: UK multicentre trial in acute hospital setting. PARTICIPANTS: Adults with sickle cell disease of any gender and phenotype aged 16 years and over. INTERVENTIONS: Oral ibuprofen at a dose of 800 mg three times daily or placebo in addition to opioids (morphine or diamorphine) administered via PCA pump for up to 4 days. MAIN OUTCOME MEASURES: The primary outcome measure was opioid consumption over 4 days following randomisation. RESULTS: The SWIM trial closed early because it failed to randomise to its target of 316 patients within a reasonable time. CONCLUSIONS: The key issues identified include the unanticipated length of time between informed consent and randomisation, difficulties in randomisation of patients in busy emergency departments, availability of trained staff at weekends and out of hours, fewer centres than expected using PCA routinely for sickle cell pain treatment, lack of research staff and support for participation, and the trial design. There are implications for future UK trials in sickle cell disease. TRIAL REGISTRATION NUMBER: ISRCTN97241637, NCT00880373; Pre-results. |
format | Online Article Text |
id | pubmed-4908891 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-49088912016-06-22 SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt Cho, Gavin Anie, Kofi A Buckton, Jacky Kiilu, Patricia Layton, Mark Alexander, Lydia Hemmaway, Claire Sutton, Dorothy Amos, Claire Doré, Caroline J Kahan, Brennan Meredith, Sarah BMJ Open Haematology (Incl Blood Transfusion) OBJECTIVES: Sickle With Ibuprofen and Morphine (SWIM) trial was designed to assess whether co-administration of ibuprofen (a non-steroidal anti-inflammatory drug) resulted in a reduction of opioid consumption delivered by patient-controlled analgesia (PCA) for acute pain in sickle cell disease. DESIGN: A randomised, placebo-controlled, double-blind trial. SETTING: UK multicentre trial in acute hospital setting. PARTICIPANTS: Adults with sickle cell disease of any gender and phenotype aged 16 years and over. INTERVENTIONS: Oral ibuprofen at a dose of 800 mg three times daily or placebo in addition to opioids (morphine or diamorphine) administered via PCA pump for up to 4 days. MAIN OUTCOME MEASURES: The primary outcome measure was opioid consumption over 4 days following randomisation. RESULTS: The SWIM trial closed early because it failed to randomise to its target of 316 patients within a reasonable time. CONCLUSIONS: The key issues identified include the unanticipated length of time between informed consent and randomisation, difficulties in randomisation of patients in busy emergency departments, availability of trained staff at weekends and out of hours, fewer centres than expected using PCA routinely for sickle cell pain treatment, lack of research staff and support for participation, and the trial design. There are implications for future UK trials in sickle cell disease. TRIAL REGISTRATION NUMBER: ISRCTN97241637, NCT00880373; Pre-results. BMJ Publishing Group 2016-06-09 /pmc/articles/PMC4908891/ /pubmed/27288381 http://dx.doi.org/10.1136/bmjopen-2016-011276 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ |
spellingShingle | Haematology (Incl Blood Transfusion) Cho, Gavin Anie, Kofi A Buckton, Jacky Kiilu, Patricia Layton, Mark Alexander, Lydia Hemmaway, Claire Sutton, Dorothy Amos, Claire Doré, Caroline J Kahan, Brennan Meredith, Sarah SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt |
title | SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt |
title_full | SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt |
title_fullStr | SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt |
title_full_unstemmed | SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt |
title_short | SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt |
title_sort | swim (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt |
topic | Haematology (Incl Blood Transfusion) |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4908891/ https://www.ncbi.nlm.nih.gov/pubmed/27288381 http://dx.doi.org/10.1136/bmjopen-2016-011276 |
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