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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.)
Sponsor:
Collaborator:
Medical Research Council CTU
Information provided by:
London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT00880373
First received: April 9, 2009
Last updated: December 3, 2012
Last verified: December 2012

April 9, 2009
December 3, 2012
March 2011
March 2014   (final data collection date for primary outcome measure)
Patient controlled analgesia (PCA)diamorphine or morphine consumption [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Patient controlled analgesia (PCA) morphine consumption [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00880373 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine
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

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sickle Cell Disease
  • Drug: Ibuprofen
    Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
  • Drug: Placebo
    Matching placebo three times daily for 4 days
  • Drug: Diamorphine or Morphine
    Diamorphine or Morphine by PCA
  • Active Comparator: 1
    Diamorphine or Morphine by PCA and oral ibuprofen
    Interventions:
    • Drug: Ibuprofen
    • Drug: Diamorphine or Morphine
  • Placebo Comparator: 2
    Diamorphine or Morphine by PCA and oral placebo
    Interventions:
    • Drug: Placebo
    • Drug: Diamorphine or Morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
320
August 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00880373
HTA 07/48/01, ISRCTN97241637
Yes
Dr Kofi Anie, North West London Hospitals NHS Trust
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
London North West Healthcare NHS Trust
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP