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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00880373
Recruitment Status : 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.)
First Posted : April 13, 2009
Last Update Posted : December 4, 2012
Medical Research Council CTU
Information provided by:
London North West Healthcare NHS Trust

Brief Summary:
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 or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Ibuprofen Drug: Placebo Drug: Diamorphine or Morphine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : August 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Patient controlled analgesia (PCA)diamorphine or morphine consumption [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00880373

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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
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Kofi Anie, North West London Hospitals NHS Trust Identifier: NCT00880373    
Other Study ID Numbers: HTA 07/48/01
First Posted: April 13, 2009    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012
Keywords provided by London North West Healthcare NHS Trust:
Sickle Cell Disease
Patient Controlled Analgesia
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Acute Pain
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action