Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine (SWIM)

This study has been terminated.
(The funding withdrawal and early termination of the trial is based upon lack of suitable recruitment figures in order to reach the required trial endpoints.)
Medical Research Council CTU
Information provided by:
London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier:
First received: April 9, 2009
Last updated: December 3, 2012
Last verified: December 2012
The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).

Condition Intervention Phase
Sickle Cell Disease
Drug: Ibuprofen
Drug: Placebo
Drug: Diamorphine or Morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of the Effectiveness of Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial

Resource links provided by NLM:

Further study details as provided by London North West Healthcare NHS Trust:

Primary Outcome Measures:
  • Patient controlled analgesia (PCA)diamorphine or morphine consumption [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: March 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Diamorphine or Morphine by PCA and oral ibuprofen
Drug: Ibuprofen
Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
Drug: Diamorphine or Morphine
Diamorphine or Morphine by PCA
Placebo Comparator: 2
Diamorphine or Morphine by PCA and oral placebo
Drug: Placebo
Matching placebo three times daily for 4 days
Drug: Diamorphine or Morphine
Diamorphine or Morphine by PCA

Detailed Description:

Pain from vaso-occlusion in sickle cell disease (SCD) is persistent, and its management continues to pose a challenge to practitioners. Opioids are recommended for the treatment of severe acute SCD pain, and have been used successfully within the hospital setting. Non-steroidal Anti-Inflammatory Drugs (NSAIDs) are recommended for acute SCD pain, however there is no clear evidence for the effectiveness of oral NSAIDs in combination with parenteral opioids in adults with SCD.Data from acute pain research suggests that oral ibuprofen is one of the best NSAIDs for combination treatment with morphine via PCA.

This is a randomised controlled trail to evaluate the effectiveness of oral ibuprofen plus intravenous Diamorphine or morphine via PCA. The results will provide the evidence needed to recommend whether or not ibuprofen should be used in acute SCD pain.


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients with SCD of any phenotype

Exclusion Criteria:

  • Patient has a history of allergic reaction to either diamorphine/morphine or ibuprofen
  • Patient has contraindications to diamorphine/morphine or ibuprofen, e.g. peptic ulcer disease, non-steroidal anti-inflammatory drug (NSAID)-induced asthma
  • Patient in a drug dependency programme
  • Patient is on renal dialysis
  • Stroke within the last 6 weeks
  • Platelet count less than 50 x 10^9/l
  • Patient is pregnant or breastfeeding
  • Doctor unwilling to randomise the patient for other reasons
  • Previous participation in the trial
  • Patient receiving drug treatment with which opioids or NSAIDs are likely to interact significantly
  • Stage 1 - 5 chronic kidney disease (ref Appendix 2), including urine protein: creatinine ratio of >50 (Because the ibuprofen dose is substantial it is felt that precautions should be taken to exclude those who have any signs of chronic kidney disease. One of the signs of kidney disease is "persistent proteinuria". Therefore, the patient who intermittently has proteinuria(which could be due to other reasons) could still participate.)
  • Oxygen saturation by pulse oximetry <94%
  • Participation in another clinical trial within the last month
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00880373

United Kingdom
North West London Hospitals NHS Trust
London, United Kingdom, NW10 7NS
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
London North West Healthcare NHS Trust
Medical Research Council CTU
Principal Investigator: Kofi A Anie, PhD London North West Healthcare NHS Trust
Study Chair: Gavin Cho, MD London North West Healthcare NHS Trust
Principal Investigator: Mark Layton, MD Imperial College London
Study Director: Sarah Meredith, MD MRC Clinical Trials Unit
Study Director: Caroline Dore, BSc MRC Clinical Trials Unit
  More Information

Responsible Party: Dr Kofi Anie, North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00880373     History of Changes
Other Study ID Numbers: HTA 07/48/01  ISRCTN97241637 
Study First Received: April 9, 2009
Last Updated: December 3, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by London North West Healthcare NHS Trust:
Sickle Cell Disease
Patient Controlled Analgesia

Additional relevant MeSH terms:
Acute Pain
Anemia, Sickle Cell
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 25, 2016