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



A randomised, placebo-controlled, double-blind trial.



UK multicentre trial in acute hospital setting.



Adults with sickle cell disease of any gender and phenotype aged 16 years and over.



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.



The primary outcome measure was opioid consumption over 4 days following randomisation.



The SWIM trial closed early because it failed to randomise to its target of 316 patients within a reasonable time.



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.



ISRCTN97241637, NCT00880373; Pre-results.
Haematology and Sickle Cell Centre, London North West Healthcare NHS Trust, Central Middlesex Hospital, London, UK.
Gavin
G
Cho
Haematology and Sickle Cell Centre, London North West Healthcare NHS Trust, Central Middlesex Hospital, London, UK Faculty of Medicine, Imperial College London, London, UK.
Kofi A
KA
Anie
Haematology and Sickle Cell Centre, London North West Healthcare NHS Trust, Central Middlesex Hospital, London, UK.
Jacky
J
Buckton
Haematology and Sickle Cell Centre, London North West Healthcare NHS Trust, Central Middlesex Hospital, London, UK.
Patricia
P
Kiilu
Department of Haematology, Imperial College London, Hammersmith Hospital Campus, London, UK.
Mark
M
Layton
Department of Haematology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK.
Lydia
L
Alexander
Department of Haematology, Barking, Havering and Redbridge University Hospitals NHS Trust, Queen's Hospital, Romford, Essex, UK.
Claire
C
Hemmaway
Department of Haematology, Barking, Havering and Redbridge University Hospitals NHS Trust, Queen's Hospital, Romford, Essex, UK.
Dorothy
D
Sutton
MRC Clinical Trials Unit, University College London, London, UK.
Claire
C
Amos
MRC Clinical Trials Unit, University College London, London, UK.
Caroline J
CJ
Doré
MRC Clinical Trials Unit, University College London, London, UK.
Brennan
B
Kahan
MRC Clinical Trials Unit, University College London, London, UK.
Sarah
S
Meredith
D000284:Administration, Oral; D000328:Adult; D016058:Analgesia, Patient-Controlled / Q000379:methods*; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D000755:Anemia, Sickle Cell / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage*; D017063:Outcome Assessment, Health Care; D010146:Pain / Q000188:drug therapy*; D006113:United Kingdom / Q000453:epidemiology
D000701:Analgesics, Opioid; D009020:Morphine; D007052:Ibuprofen
ACCIDENT & EMERGENCY MEDICINE; IBUPROFEN; OPIOIDS; PAIN MANAGEMENT; SICKLE CELL DISEASE