SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt

Gavin Cho, Kofi A Anie, Jacky Buckton, Patricia Kiilu, Mark Layton, Lydia Alexander, Claire Hemmaway, Dorothy Sutton, Claire Amos, Caroline J Doré, Brennan Kahan, Sarah Meredith, Gavin Cho, Kofi A Anie, Jacky Buckton, Patricia Kiilu, Mark Layton, Lydia Alexander, Claire Hemmaway, Dorothy Sutton, Claire Amos, Caroline J Doré, Brennan Kahan, Sarah Meredith

Abstract

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.

Keywords: ACCIDENT & EMERGENCY MEDICINE; IBUPROFEN; OPIOIDS; PAIN MANAGEMENT; SICKLE CELL DISEASE.

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/

Figures

Figure 1
Figure 1
Flow chart of patient recruitment at SWIM trial closure.

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Source: PubMed

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