Status:
TERMINATED
Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine
Lead Sponsor:
London North West Healthcare NHS Trust
Collaborating Sponsors:
Medical Research Council CTU
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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 sickl...
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 pa...
Eligibility Criteria
Inclusion
- Adult patients with SCD of any phenotype
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00880373
Start Date
March 1 2011
End Date
August 1 2014
Last Update
December 4 2012
Active Locations (2)
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1
North West London Hospitals NHS Trust
London, United Kingdom, NW10 7NS
2
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS